I. Introduction
II. Background information concerning Pakistan
III. Drug legislation in Pakistan
IV. Registration of drugs 2
V. Pakistan Narcotics Control Board (PNCB)
VI. Policy regarding opiates
VII. Health education on drug abuse control
Acknowledgements
Author: Inayat KHAN , Khanzada Abdul WADUD
Pages: 21 to 40
Creation Date: 1977/01/01
The objective of this paper is to review the drug abuse control programme in Pakistan, with particular reference to measures aimed at reducing the demand for narcotic drugs. Its underlying aim is to appraise the drug policy of the Government, to highlight significant achievements, and to identify areas in which the Government's efforts would be enhanced by minimal international support. Recognizing that a reduction in the demand for drugs of abuse is one aspect of the total effort to contain the menace, the authors have paid special attention to the need for active participation by the medical profession to assume specific responsibilities for achieving national goals.
The paper is based largely on interviews with officials of the Pakistan Narcotics Control Board (PNCB), the Federal Ministry of Health, the Provincial Health and Excise Departments, members of the medical profession, and other research workers. In addition to visits to Islamabad where the headquarters of the PNCB and the Federal Ministry of Health are located, a visit was also made to the adjacent city of Rawalpindi. Extensive exploratory studies were made in Karachi, in Sind and in Peshawar, Mardan, Abbotabad, Malakand, Buner and Swat of the Northwest Frontier Province. Plans by the authors to pay similar visits to the capital cities of Punjab and Baluchistan did not materialize because of time limitations and the adverse weather conditions prevailing at the time. However, the latter situation has not resulted in serious gaps in the study as a whole, since it was fortunately possible to cover certain important areas subsequently through discussions at Islamabad with policy-makers and technical specialists from the two provinces. It would not, therefore, be over-ambitious to affirm that the situation in Pakistan is covered comprehensively in this paper.
* Note by the Editor. A multi-sectoral country programme on drug abuse control has been initiated with the financial assistance of the United Nations Fund for Drug Abuse Control. This paper provides insight into the particular conditions prevailing in the country.
(a) Information of a general nature
The State of Pakistan was created on 14 August 1947 in an atmosphere of extreme political tension arising from opposition to the partitioning of the Indian sub-continent. The tension culminated in an open manifestation of bitterness and violence and a large-scale exodus of population from the two new countries. This mass migration was not without problems for the new State(s) and left a definite impact on the course of future events. The drug abuse policies of the Governments concerned have certainly been closely affected by the events of the time.
At the time of its creation, Pakistan consisted of East and West Pakistan; however, the great political upheavals of 1971 led to secession of the former, now known as the State of Bangladesh.
As it exists today, Pakistan has a total land area of 310,000 square miles (803,940 km2) and has a population of 73.4 million (1977) unevenly distributed over four Provinces as follows:
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Population (in thousands) approximately |
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|---|---|---|
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1.
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Northwest Frontier Province (including tribal areas)
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10 909 |
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2.
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Punjab Province (including Federal territory)
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37 609 |
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3.
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Sind Province
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13 965 |
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4.
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Baluchistan Province
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2 409 |
The country has common borders with Afghanistan in the northwest, Iran in the west, India in the east and southeast and China across the disputed Jammu and Kashmir Territory in the north. To the south, the long coastline stretches along the Arabian Sea (see map I on page 22).
Agriculture contributes the bulk of the gross national product and is the mainstay of the country's economy. Nearly, 80 per cent of the working population is employed, or depends, on agriculture. The per capita gross income is 1,701 rupees. The high growth rate of industries, the focal point of Government policy in the past, has caused a considerable shift in the rural population to the bigger cities, with many concomitant social problems. Since there are four main spoken languages in the different ethnic groups, the population shifts were, in some cases, accompanied by the concentration of such groups in certain specific areas and these, in the course of time, have become conglomerates characterizing uniform social behaviour and outlook. The recent changes in government policy, with an emphasis on developing the rural community as an independent economic entity and on the recognition of its contribution to the development process within the national context, is expected to reverse or at least curtail the trend to a large extent. However, although the four Provinces are characterized by linguistic dissimilarities (Pushto, Punjabi, Sindi, and Baluchi, with their dialects) within distinct geographical boundaries, the uniformity of religious and social values and a common socio-cultural background are preponderant factors creating a national identity. Urdu is the official language and, except in remote rural hamlets, is spoken and understood throughout the country. English is the official medium of communication at the national and provincial levels. Nearly all government officials are fluent in both English and Urdu while almost all also have a command of one or more regional languages. Islam is the universal religion, and is practised by the majority of the population with a traditional tolerance and respect for religious minorities including Hindus, Buddhists, Parsis, Christians and others. The rights of these minorities are adequately protected by constitutional safeguards ensuring their representation and participation at all levels.
The 1973 Constitution is based on a Federal type of Parliamentary Democracy with an Upper House (the Senate) and a Lower House (the National Assembly). All the four Provinces are represented on the basis of population in the National Assembly and have proportional representation, through indirect election, in the Senate. The Federal area (Islamabad), the religious minorities and the Federally Administered Tribal Areas have reserved seats both in the National Assembly and the Senate. The President is the Constitutional Head of State, but the Prime Minister, with the assistance of the Council of Ministers, conducts national and foreign affairs. At the provincial level, the implementation of Federal policies is supervised by the President's agent (appointed by or with the consent of the Prime Minister), viz. the Provincial Governor. The four Provinces are guaranteed maximum autonomy by the Constitution. Each Province has a Provincial Assembly consisting of elected public representatives from all areas and groups. The highest executive in each Province is the Chief Minister who fulfils his constitutional functions with the help of his Council of Ministers and is answerable to the Provincial Assembly. As regards the distribution of powers, the Constitution establishes three lists, namely: (i) the Federal Legislative List; (ii) the Concurrent Legislative List; and (iii) the Residuary List, covering matters not enumerated in any of the above two lists. Each item of national significance falls into one or more lists and, depending on its classification, is the responsibility of either the Federal or Provincial Governments or both. To cite an example, opium appears on the Concurrent Legislative List and is hence the responsibility of both the Federal and Provincial Governments. For the purpose of discussing interprovincial issues, the Provincial Coordination Committee, chaired by a Federal Minister, has been formed. This holds regular meetings with the aim of co-ordinating provincial efforts with national endeavours.
The economic backwardness of the country is reflected in the many unfulfilled social aspirations, for example, lack of full medical care coverage accompanied by a low standard of living, a low rate of literacy, and deficient social and cultural conditions.
The urban population of 21,000,000 (in 1977) is concentrated in a few large cities, while the rural population of 52,430,000 is scattered over 500,000 villages throughout the country some inaccessible because of terrain difficulties while others are blocked off seasonally due to inclement weather conditions. Although social services have been considerably improved, their further extension is still fraught with many difficulties and problems in view of the existing conditions. At the time of independence in 1947, there was only one doctor for every 23,500 inhabitants and one hospital bed for every 2,324 persons. Infant mortality was at the staggering level of 235 per thousand, and the statistics as regards maternity mortality and epidemics were dismal. To overcome these problems in the health sector, medical education and the eradication of communicable diseases became a national priority. The results of the efforts made were evident in 1977 when the ratio of doctors to inhabitants had improved to one for every 6,900 persons. The total budgetary allocation for the health sector was 2,100,000,000 rupees (Rs. 9.9 = $1) (19701977), while the number of medical colleges increased from one in 1947 to fifteen in 1976. The number of medical students admitted annually had risen to 4,000. By the end of 1976, the situation improved to one doctor for every 6,900 inhabitants and one hospital bed for every 1,670 persons.
In education, as in health, the Federal and Provincial Governments are concentrating on the practical aspects of training of students as well as on attempting to shape their personalities to meet the national aspirations of self-respecting productive citizens living in harmony with society at large. Since it is not our intention to comment at any length on the over-all education policy of the Government, suffice it to mention that the programme now in operation and that envisaged for the future should have produced, inter alia, a large number of enthusiastic, socially oriented workers attaining a level of physical and mental maturity indispensable for the country's drive to combat drug abuse and other social evils.
The soils and climate of Pakistan are favourable to the growth of many medicinal plants producing various pharmacologically active substances. Some of these plants grow wild ( Cannabis sativa and species of Artemesiaand Ephedra) and, as the healing and euphoric characteristics of some of them gain credence with communities, like e.g. Artemesia, they are beginning to be used and commercially exploited. There are still others which can be exploited and put to better use than at present, e.g. species of Dioscorea and Datura.
Among the medicinal plants, Papaver somniferum, which exists mostly in the cultivated form, has been similarly exploited over the centuries. It was a major source of revenue in the Moghul period and continued as such during the British period; indeed, at one stage it is said to have contributed as much as 19 per cent of the entire revenue of British India. The medical practitioners of old - the predecessors of present-day physicians - were familiar with the medicinal herbs and used various preparations in their practice (dhoda or capsule, opium seed and powdered opium).
(b) Information on specific Provinces
Northwest Frontier Province (NWFP). The problems of drug abuse have many ramifications but space limitations clearly necessitate that primary attention be paid to supply-demand aspects in the light of the over-all problem as described above. Since opium is produced almost exclusively in the NWFP, a brief description of the social and administrative set-up would be helpful in understanding the complex nature of the problem.
The NWFP, which has a gross area of 25.14 million acres, is largely, made up of hilly terrain, with only 3.05 million acres being cultivated under rain-fed and irrigated conditions. Although 1.15 million acres are under some sort of irrigation, the average productivity is low and mostly dependent on favourable weather conditions. An Overwhelming majority of the population (almost 80 per cent) depend on a living eked out from agriculture which reportedly constitutes 40 per cent of the Gross Regional Product. Many children drop out of school because they have to assist their parents living off the farm. Given the scant knowledge of modern agriculture, the meagre resources to procure better seeds and fertilizers, inadequate supply of water and the out-dated implements, the farmers are left with little choice of other crops. They are obliged by circumstances to meet the needs of the domestic consumption and their cash requirements. Wheat and the opium poppy are the crops upon. which they are most dependent for their requirements. The Province is sub-divided into three distinct administrative units, namely the Settled Districts, the Merged Areas and the Tribal Areas.
The Settled Districts. In the Settled Districts, which are nine in number and under the total administrative control of the Government, all the ordinary legislation of the country as well as the narcotic laws are in force. 1 An elaborate licensing system regulates cultivation of the opium poppy within a compact area and ensures that the entire produce is surrendered to the Government. The equally elaborate land measurement records help in maintaining a reasonable check on the areas brought under cultivation and the yield declared by the growers. Procedures and control are adequately covered under the Opium Act of 1857 (see page 30).
In Pakistan opium production is covered under a dual system. In the settled districts control is made effective by application of narcotic laws, while in the tribal territory these laws are not applicable, and thus opium production is practically not banned by existing laws.
The Merged Areas. These areas are the erstwhile Princely States and were mostly brought within the provincial administration in 1969. These States were previously ruled by authoritarian princes whose main interest lay in the revenues accruing to them. The farmers were free to cultivate any crop so long as a fixed share was surrendered to the State. However, since their merger into the provincial administration, the narcotics laws have been extended to all these States although their application is not yet effective because of certain administrative reasons. The greatest difficulty is a total lack of land area records and ownership rights, and these factors in themselves would defy the application of even the basic provisions of the Opium Act. These States are more appropriately referred to as the Provincially Administered Merged Areas, which are the Districts of Chitral, Swat, Dir and the attached area of Mardan known as Gadoon.
The Tribal Areas. The Tribal Areas, also known as the Federally Administered Tribal Areas, stretch in a narrow belt along the western side of the NWFP on the border between Pakistan and Afghanistan, the area being 10,000 square miles and the population 2,504,000. Included in these areas are the Khyber Agency, Kurram Agency, Mohmand Agency, Bajaur Agency, North and South Waziristan Agencies, Orakzai Agency and the special areas attached with Peshawar, Kohat and Bannu. None of the ordinary laws of the country (including the narcotic laws) are applicable to these areas. Theoretically, therefore, the cultivation of the opium poppy is uncontrolled and the produce is disposed of illicitly. Because these are politically sensitive areas, extensions of administrative and legal control have to follow a phased programme, preferably preceded by a show of impressive development activity. Large tracts in the Tribal and Merged Areas would seem to be unfit for the economic production of crops other than the opium poppy and its eradication without first activating plans aimed at income substitution could prove disastrous.
The people of this Province are known as Pukhtoons, Pushtoons or Pathans and, with minor dialectal variations, speak a common language, known as Pukhto or Pushto, although Hindu, Urdu and Punjabi are also spoken in the cities. The history of the Pathans reaches far into the past and is prominently mentioned in the writing of renowned historians including Herodotus. The Pathans gave battle to all invaders and resisted incursions into their territory until the British period during which, perhaps, their freedom-loving nature found its best expression. All along their history, the Pathans have been a strife-torn race internally although instances of unity against common dangers are not rare. The Pathans are predominantly Muslims and opted for Pakistan in a referendum held in early 1947. It is because of an identity of goals that the Pathans have been peaceful in Pakistan although it is only recently that they have begun participation in economic activities. A change of orientation, apart from being unwelcome to them, is also likely to be unwholesome in the long run.
Swat. Swat, One of the nine districts of the NWFP, was a Princely State until 1969, when it was merged into the normal administrative structure of the Province. It is a scenic tourist resort area, spread over 4,000 square miles and has a population of 936,000. Buner, which was chosen as a pilot area and where the joint Pakistan/UN project was initiated in July 1976, is its southern sub-division with less developed resources and much less favoured by nature (see map No. 2 on page 27). The population of 200,000 is scattered over 700 square miles of eroded and mountainous terrain and depends entirely on subsistence agriculture. The main crop, which ensures a steady income, including ready cash, is the opium poppy. It is estimated that nearly one-third of the total yield of the opium poppy comes from Buner.
The UN-supported project referred to above is aimed at assisting the community in improving the yield of existing crops other than the poppy through a number of measures such as the sinking of wells, land levelling, water management, better agricultural expertise, and improved methods for the application of seeds and fertilizers. Development of livestock, extension of credit facilities and marketing are some of the other activities which should assist farmers to match their income and readily available cash from poppies.
Although Buner is a major poppy-growing area, the incidence of addiction has followed a unique pattern of restricted concentration rather than widespread prevalence. There is only one village, Kuria, where the majority of the 900 population are opium addicts in one form or another. It has been estimated that 12.5 per cent are opium smokers or eaters (the ratio of smokers to eaters being I to 5). Although the total number (estimated at 150) is not large, concentration at one place has been assumed to be justification for establishing a pilot treatment and rehabilitation clinic at the nearby Government Chamla Hospital. It would certainly be interesting to study the results obtained at this clinic and these would enable an appropriate extension of such facilities to other areas of the Swat District where, according to all visible indications, addiction may be on a much larger scale and, perhaps, to still more harmful drugs.
It may be mentioned that as part of the same project, treatment and rehabilitation clinics are also to be established at Karachi, Hyderabad, Lahore, Quetta, Rawalpindi and Peshawar, as well as at Buner.
(c) Information on the country's approach to drug abuse control
The authors held a series of interviews with the Chairman of the PNCB, (Sahibzada Raoof Ali) with the aim of determining the evolution of the country's drug abuse policy and formulating their findings in a concise manner for the convenience of policymakers. The Chairman informed us that an integrated policy was yet to take shape, although various types of information and data based on historical, economic, social, cultural and religious conditions could provide a solid background for the formulation of such a policy.
The agreement signed on 5 May 1976 between the Government of Pakistan and the United Nations Fund for Drug Abuse Control is one outcome of the recognition of the need for a policy. It should be noted that the Ministries of Health, Social Welfare and Labour as well as other Government Ministries are fully aware of the hazards associated with drugs. Thus, during the 29th World Health Assembly in Geneva, the Federal Minister of Health referred to the drug legislation enacted in 1976 and declared it to be on a par with comparable legislation in any developed country. Viewed against the background of cognizance at such levels, the compulsory registration of individual drugs, pharmaceutical licensing and the control of drug advertising, introduced for the first time in the history of Pakistan, may well be visualized as the precursors for evolving a drug policy. These control measures will obviously have far-reaching effects on the ready availability of drugs without prescription on the one hand and the non-medical use of dangerous drugs on the other.
The Government of Pakistan promulgated the Drugs Ordinance in January 1976; this was subsequently approved by Parliament in the form of "The Drugs Act, 1976". The latter supersedes the Drug Act, 1940; the Drug (Generic Names) Act, 1972 and the Drugs Ordinance, 1976.
The Act controls the manufacture, registration, advertising and pricing of drugs and, in accordance with WHO recommendations, lays emphasis on good manufacturing practices. A series of detailed regulations have now been made in pursuance of the Act. The previously existing procedures have been simplified and made more effective in order to ensure the availability of safe, effective and high-quality drugs at reasonable prices. A significant aspect of the new legislation is the establishment of two Drug Courts (Punjab and NWFP - Lahore; Sind and Baluchistan - Karachi), composed of a judge of the High Court and two experts in the medical or pharmaceutical fields: they hear cases of violations against the Act.
The Single Convention on Narcotic Drugs, 1961, lists about 100 drugs of which 15 are of special interest as single- or multiple-ingredient drugs used in Pakistan. Some of these drugs are covered by the Dangerous Drugs Act of 1930 and include coca leaf and its preparations, opium and its preparations, cannabis and its preparations, and derivatives of opium, etc. Other drugs, scheduled in the Single Convention such as diphenoxylate, pholcodine, etc., are controlled under the Drugs Act.
Control on storage and use of dangerous drugs listed under the Single Convention is exercised by the Provincial Excise Departments under the provisions of the Dangerous Drugs Act, 1930. For the purpose of importation, dangerous drugs mentioned in the Single Convention are dealt with in accordance with the provisions of the Dangerous Drugs Act, 1930.
The definition of dangerous drugs covers coca leaf, cannabis and opium together with their derivatives and may be extended to include any other drug considered dangerous. The term "opium" has been modified to include a number of drugs obtained from opium both in the crude form and as pharmaceutical preparations.
The principal federal laws regulating and controlling narcotic drugs in Pakistan are as follows:
The Dangerous Drugs. Act, 1930;
The Opium Act, 1857;
The Opium Act, 1878;
The West Pakistan Prohibition of Opium Smoking Act, 1958.
Besides, the following provincial laws are also applicable in the various provinces:
The Punjab Excise Act of 1914;
The Sind Abkari Act of 1878;
The NWFP Prohibition Act of 1938;
The Baluchistan Control on Possession and Consumption Act of 1973.
Under the Dangerous Drugs Act, 1930; the Opium Act, 1857; the Opium Act, 1878 and the West Pakistan Prohibition of Opium Smoking Act 1958 it is an offence to possess, manufacture, transport, import, export and sell any "dangerous drug" or to undertake cultivation, collection and adapting for smoking opium poppy, hemp or the coca plant. Violation is punishable by up to 2 years of imprisonment or a fine of up to Rs. 2,000 (Rs. 9.9 = $1), or both. The proposed new legislation, the Narcotic Drugs Act, 1977, would establish much more severe and deterrent penalties.
It should be borne in mind that even under the existing comparatively lenient legislation the various enforcement agencies, i.e. the Federal and Provincial Excise, Police, Customs, Revenue Departments and the Pakistan Narcotics Control Board, have operated reasonably effectively. In Punjab alone, 2,060 offences against the dangerous drug laws were detected during 1974, out of which there were 945 convictions and 315 acquittals.
Control of the manufacture of dangerous drugs is now exercised through the Central Licensing and Registration Boards, while their sale remains the responsibility of the Provincial Governments. These drugs may be dispensed only on medical advice and dispensing must be authenticated by the keeping of appropriate records by chemists and druggists for examination by the inspectors of the Excise Departments.
As Pakistan develops facilities for the treatment and rehabilitation of drugdependent persons, the need for new compounds will inevitably arise. Rules have consequently been drafted for these and other requirements, including research on humans and animals to be undertaken by the pharmaceutical industry in respect of all types of drugs. However, elaborate rules regarding drugs with dependence liability and abuse potential have yet to be framed.
As a result of the regulatory provisions referred to above, the Government has now brought drug advertising under strict control for the first time. It is no longer possible to openly advertise drugs for the treatment of certain diseases. As a consequence, radio, television, newspapers, etc. no longer carry indiscriminate advertisements by manufacturers. However, there is still an urgent need to include drug-dependent persons under the new legal framework and hence the 1976 legislation must be further strengthened.
Subsequent to the ratification in June 1977 by Pakistan of the Convention on Psychotropic Substances of 1971, the Government presently considers the formulation of rules under which drugs in the Schedules of the Convention will be placed under a separate list in order to exercise adequate control, as required. At the moment amobarbital, glutethimide and pentobarbital from Schedule II, and meprobamate and phenobarbital from Schedule IV, have been registered by the Ministry of Health, and are controlled under the Drugs Act, 1976.
The 1976 Drugs Act described in the preceding section provides for the registration of all drugs that are to be imported into, or manufactured and sold in, Pakistan. Registration is an essential requirement of any modern drug legislation, but this is the first time that the concept has been introduced in Pakistan. It is through this important instrument that developing and developed countries throughout the world ensure the quality, efficacy and safety of a drug before it is released for marketing.
2The authors would like to thank Dr. F. R.Y. Fazli of the Ministry of Health of Islamabad for contributing this section
Registration aims at the evaluation of a drug in terms of its prophylactic or therapeutic use and ensures suitability of its specifications in terms of identity, strength, purity and other characteristics.
The process can be very exhaustive and demanding, as in the USA, whereas it may be relatively simple in the developing countries, where the health authorities may frame rules for registration based on the experience of other countries. Applications for the registration of a drug must provide information about the manufacturer as well as its composition, methods of manufacture, quality control procedures, therapeutic indications, side effects, contra-indications, recommended dosage, prices and other aspects. Under the 1976 Act, a Registration Board has been set up, with the following membership: ( a) the Director-General, Health, who is its ex-officio Chairman; ( b) a professor in a clinical subject; ( c) a professor of pharmacology; ( d) the Deputy Director-General, Health; ( e) a pharmaceutical chemist; ( f) a medical specialist from the Army Medical Corps; ( g) an official from the Drugs Administration, who acts as the Secretary of the Board.
The Board has established the following standards to be fulfilled by manufacturing firms for the registration of drugs manufactured by them: ( a) firms should be licensed by the Central Licensing Board find must follow good manufacturing practices; ( b) firms must have the necessary technical knowhow and the capacity to acquire and utilize the requisite equipment; ( c) firms must sell their products at prices fixed by the Government, these prices being on a par with those prevailing in 1971; ( d) firms which are subsidiaries of foreign firms must have permission to sell their products and must hold a guarantee of good manufacturing practice issued by the health authorities in the country of origin; ( e) firms must provide satisfactory information regarding specifications (identity, strength and purity) as well as pharmacological, toxicological and clinical characteristics; ( f) firms should have satisfactory models of labels and package inserts.
The following criteria have been established for the registration of drugs manufactured abroad: ( a) evidence must be provided that permission has been granted to sell the product in the country of origin, and a certificate of good manufacturing practices issued in that country must also be provided; ( b) the drugs must be of good quality and have been manufactured by firms of high repute; ( c) the drugs must not be harmful and must not have been declared unsuitable by the United States Food and Drug Administration; ( d) satisfactory information must be provided regarding specifications of the drug (identity, strength and purity) as well as pharmacological, toxicological and clinical characteristics; ( e) models of labels and package inserts must be satisfactory.
The Board has so far registered nearly 1,500 drugs and the decisions regarding registration have been conveyed to the firms concerned. Simultaneously with the granting of registration, the name of the drug, its exact composition, the package size and the price are approved. At the same time claims of quality, toxic effects, contra-indications, etc. must be made. Certain drugs have not been registered, on account of doubtful quality or the existence of harmful side effects, e.g. posterior pituitary injections, and dependence-producing drugs such as dexedrine or preparations containing codeine.
The importance and necessity of careful scrutiny before registration of a drug is evident from the following extract from a report of the Director-General of the World Health Organization: 3
Drugs not authorized for sale in the country of origin - or withdrawn from the market for reasons of safety or lack of efficacy - are sometimes exported and marketed in developing countries; other drugs are promoted and advertised in those countries for indications that are not approved by the regulatory agencies of the countries of origin. Products not meeting the quality requirements of the exporting country, including products beyond their expiry date, may be exported to developing countries that are not in a position to carry out quality control measures. While these practices may conform to legal requirements, they are unethical and detrimental to health.
It has also been recognized by WHO that it is not possible for exporting countries to go beyond a certain point in their consideration of the needs of importing countries. It is natural for exporting countries to be guided by profit motives. It is, therefore, for the importing country to set conditions, specifications, assurances and guarantees on the drugs purchased.
Surveys conducted by WHO and by certain countries indicate that the number of drugs normally prescribed by a doctor is not more than 100. However, depending on drug registration policy, the number of drugs on the market in different countries varies widely, from less than 2,000 to more than 100,000. In countries having sophisticated registration and evaluation systems, there is a tendency to restrict the number of similar preparations with different brand names and to approve only those products which display genuine therapeutic advantages. This approach has been recommended by WHO. It is clear that countries having an excessively large number of drugs on their market are faced with the problem of reducing their number. If the number of drugs is too large, it is virtually impossible to educate doctors, pharmacists and others regarding efficacy, adverse reactions, use and misuse. While the Registration Board has been fully cognizant of this fact, the Board has taken every care to ensure that a wide choice of drugs is available to doctors for treatment of each disease.
The Pakistan National Formulary, which includes all registered drugs, has now been published in pursuance of the 1976 Drugs Act. This Formulary includes a sufficiently large range of drugs for each group of diseases, thereby giving a wide choice to medical practitioners. The Board has also identified and registered certain imported drugs and popular brands which were needed but unavailable in the country. The drugs included in the formulary are from more than 100 local and foreign firms. In the granting of registrations, monopolies are not encouraged and competition is ensured.
Despite the careful consideration of applications (which may be submitted at any time) by the Board, a person aggrieved by a decision of the Board is entitled to appeal against a decision or can present the case to an Appellate Board.
It is clear that registration is an instrument to ensure the quality of drugs at the source. Under the new system only safe and effective drugs will be on the market. In actual fact, counterfeit, spurious and substandard drugs disappeared immediately from the shelves after promulgation of the Act, if only on account of the severe penalties imposed under the law. This is a further positive step taken by the Government for the benefit of the population and it has brought Pakistan in line with the developed countries.
3"Prophylactic and Therapeutic Substances", report by the Director-General (unpublished document A28/11, dated 3 April 1975).
One of the problems associated with drug registration is, of course, that of quality control. In this context, it may be mentioned that the Drugs Control and Research Division of the National Health Laboratories, located in Islamabad, is engaged primarily in the quality control of drugs and medicine and in research on indigenous drugs. Besides the above functions, the Division also conducts investigative work on behalf of the PNCB and other institutions.
As an example of the activities of the Division, it may be mentioned that screening tests are performed on samples of drugs transmitted by the PNCB for examination because the Board doubted their quality. Drugs that have been detected as a result of such tests include morphine, heroin, cannabis, methaqualone and barbiturates. These drugs are generally in compound form, special techniques being required for their separation. The primary technique used has been thin-layer chromatography although other methods such as spectrophotometry have also been employed.
With the creation of Pakistan on 14 August 1947, the international narcotics treaties to which British India was then signatory were no longer valid as far as the nascent State was concerned. In 1953, having recognized the need for international controls over narcotic raw materials, Pakistan signed the UN Opium Protocol with the aim of limiting the production of opium to the amounts needed for medical and scientific purposes. Furthermore, the Pakistan Narcotics Board was established in 1959 as part of the Central Revenue Board under the Ministry of Finance, its task being to function as a central agency for the fulfilment of Pakistan's responsibilities under the Protocol. Subsequently, the Single Convention on Narcotic Drugs of 1961, which superseded the earlier protocol, was ratified by Pakistan in 1965, although with certain reservations; these sought gradual implementation of the treaty requirements by limiting the use of opium to medical and scientific needs within a period of 15 years and that of "ganja", a product of cannabis, within a period of 25 years in what was then East Pakistan. By a Government Resolution of 8 March 1973 and in accordance with article 17 of the Single Convention, the central agency was reconstituted and renamed as the Pakistan Narcotics Control Board; a number of basic changes were made in the functions of the agency and its responsibilities were significantly increased. The new organization went into effective operation immediately and, with a total current membership of 11, now ensures representation from each of the four Provinces, the States and the Frontier Regions Division, the Finance Division, the Health Division, the Food and Agriculture Division and the Planning Division, as well as the Central Board of Revenue and the Special Police Establishment. The Board which is now under the administrative control of the Federal Ministry for the Interior, is headed by a high ranking full-time Chairman. In the discharge of day-to-day functions, the Chairman is assisted by a Secretary and a staff of about 1,250, the annual budget being Rs. 7,000,000 (Rs. 9.9 = $1). The staff includes officers in charge of planning and development, enforcement, intelligence, treatment and rehabilitation, and information and preventive education at the National Headquarters; there are regional offices at Lahore, Karachi, Quetta and Peshawar.
The PNCB is responsible for fulfilling the Government's obligations under the international treaties relating to drug abuse control. It collaborates closely with the Federal Ministry of Health and the Provincial Health and Excise Departments. As a result of the combined efforts of the Board and the Federal and Provincial Ministries of Health amendments to and revisions of the 1930 Dangerous Drugs Act, as well as proposed new drug legislation have been prepared. The PNCB has begun and will continue to play a major role in assessing the magnitude, pattern and trend of drug abuse, besides providing diagnostic, treatment and rehabilitation services to drug-dependent persons. It plays an equally significant role in the field of education and information; this activity underlines the Board's active support of the Federal and Provincial Ministries and other institutions in their efforts to prevent the non-medical use of drugs. On a pilot basis, the Board has also ventured into the area of development with the aim of income substitution as a long-range measure for freeing communities from dependence on natural narcotics. Blueprints for a number of projects are now being developed aiming at a reduction of the presently ever-expanding areas producing narcotic raw materials.
The PNCB has developed an efficient operational machinery to counter drug abuse by pooling the efforts of the various enforcement agencies. The establishment of 25 mobile and well-equipped Field Investigative Units, which already have to their credit numerous spectacular seizures of illicit drugs, has substantially strengthened the Government's enforcement capacity besides providing a logical basis for effective co-ordination at the Provincial, Federal and international levels.
The mandate given to the PNCB to negotiate at the international level and recommend to the Government appropriate action with regard to programmes as well as the implementation of the relevant treaties is an obvious indication of the determination of Pakistan to combat the menace of drugs alongside the other nations of the world.
(a) Historical aspects and current situation
Exponents of one popular theory assert that opium was introduced into Pakistan by the invading armies of Alexander the Great, for whose benefit adequate quantities of herbal medicines were always in stock. Whether or not the plant did in fact appear with the advent of Alexander the Great could be the subject of a separate historical study; there is, however, strong evidence to show that production began some time in the ninth century coinciding with the arrival of Arab traders. From then on the picture begins to take a definite shape. During the time of the Moghul Emperor, Akbar the Great, cultivation of the opium poppy was already being encouraged as an international cash crop for filling Government coffers. The Emperor Babar, founder of the Moghul Dynasty, himself used opium, a habit that was shared by his son Humayun and others in the lineage. This royal indulgence, which was clearly never kept secret from the public, had a great deal to do with promoting the widespread use of opium as an intoxicant as well as an easily available household remedy. This policy of primary emphasis on revenues was further reinforced with the advent of the British Raj (Government). It was the State coffers rather than long-term repercussions that caught the eye and success was marked by the earnings from the opium trade registered as the percentages of total revenues (the figure at one time was as high as 19 per cent). Study after study proved that opium users were in no way endangered from the health standpoint and that the cultivation and use of opium did not cause any threat to the Indo-Pakistan societies. The tragic consequences that ensued in China as a result of opium are widely known historical facts but the pattern it wove into the economic fabric of the rural community of Pakistan is usually ignored.
In Pakistan, poppy cultivation takes place in three administratively distinct areas of the Northwest Frontier Province, namely the Settled Districts, the Merged Areas and the Tribal Areas. In the Tribal Areas opium production is uncontrolled and the product finds its way into the illicit market mostly for indigenous consumption. Opium production in the Merged Areas, although covered by the existing narcotics laws, is not sufficiently controlled on account of the historical background of these areas, in which opium prior to 1969 was a favourite of the princely rulers. Measures are now being adopted to provide a suitable licensing system to gradually bring the cultivation of the opium poppy within Government control. Cultivation of the opium poppy in the Settled Districts is under Government control and takes place in areas designated in advance by the Provincial Excise Department in consultation with the Opium Factory at Lahore, the latter being the sole Government agency entitled to receive, store, process and supply opium. The area to be brought under cultivation each year is worked out by the Factory with due regard to the total requirement for indigenous consumption, the available stock and permissible reserves for a given period. Licit cultivation of poppy and opium production are regulated by the Opium Act of 1857. The area of licit poppy cultivation is generally restricted to two or three districts which are notified to this effect and in which licences for individual cultivators are issued on application. The licences, which are issued on a prescribed form, contain particulars of the cultivators, the location of plots and the area to be brought under such cultivation, as well as the requirements to which cultivators are subject under the terms of the 1857 Act. The latter enactment prescribes that the entire yield must be surrendered to the Government; in enforcing this provision, use is made of the influential village agents, mostly landholders who are themselves poppy cultivators.
From the time of germination until maturity and harvesting, officials of the Provincial Excise Department are constantly on the move, assessing and evaluating the crop condition and yield as a double check on what cultivators subsequently declare to be the quantity obtained. The opium or gum surrendered by the cultivators is classified provisionally by the opium officer and partial payment is made to the cultivator on the spot on that basis. Final payment is made when the authenticity of each sample has been confirmed by analysis at the Opium Factory.
All the opium gum surrendered by the cultivator is ultimately sent to the Government Opium Factory for processing, with good security measures being adopted all along the line to preclude any possibility of diversions. The crude opium is purified in the Factory and brought to 90 per cent consistency (10 per cent moisture content) for issue to Government treasuries in blocks of 933 grams each. Excise opium, as it is known after processing, is issued from Government treasuries to what are described as Government "vend shops" in quantities fixed according to their quota. There are almost 330 vend shops and the total average amount of excise opium issued to them annually is approximately 6 tons. Addicts or users receive their daily requirement of opium, not exceeding 23 grams at any one time, from these Government authorized dealers.
It has been estimated that Pakistan produces a total of 200-250 tons of opium annually. Although there are no scientifically established records, most specialists agree that the number of addicts, or regular users, is between 80,000 to 100,000. Pakistan has not yet finalized plans to register drug-dependent persons and still has to initiate the proposed programme for offering them medical care. However, it would appear that the bulk of the controlled and uncontrolled opium within the country goes to meet the need of these addicts with enough to spare for utilization by the 65,000 traditional practitioners of the Unani system of medicine whose prescriptions generally contain opium as an important ingredient. Furthermore, mothers and grandmothers use it as a readily available household remedy for a variety of chest and stomach ailments. Logically, this should leave little surplus for flow into illicit channels outside the country. In fact, the supply may already be less than the demand, and it is possible that the gap is being filled from other sources. Though such assertions may be supported by logical argumentation, their weakness is apparent. Hence, in order to establish their validity and assist the Government in the formulation of a workable policy, basic data on the number of opium addicts/users and the quantity consumed should be collected as a priority. It is only on the basis of such data that conclusive evidence one way or another could be obtained.
(b) Importation of narcotic drugs
During the year 1975, the Governments of Sind and Punjab imported directly from abroad a quota of drugs assigned to them by the Central Government on the basis of their assessment. In Punjab these drugs were distributed directly to Government institutions, while in Sind distribution was made both through the Government and private agencies. The Government of the Northwest Frontier Province permitted importation of narcotic drugs by private individuals. Baluchistan has shown no interest in such importation so far. Significantly no allocation was made to that Province during the year 1976, with the exception of diphenoxylate and pholcodine, which were distributed by the Ministry of Health to the pharmaceutical industry for use in medicinal preparations. Similarly, doctors in most need of these drugs receive their requirements in small quantities directly from the Ministry of Health, on the recommendation of the Pakistan Medical Association. Distribution of these drugs will also be made to leading chemists in every city, on the recommendation of the Chemists Association.
Codeine which costs the country Rs. 30,000,000 annually has frequently been misused in the past. A ban on its import has, therefore, been imposed and the pharmaceutical industry as well as the medical profession are being encouraged to use in its place pholcodine, which is included in the Single Convention as well as noscapine and dextromethorphan which are not so covered. In accordance with the decision of the Registration Board of the Central Government the importation of amphetamines has already been banned, while the quantities of barbiturates available for use are also being reduced to an appropriate extent.
The following is a list of drugs that were scheduled to be imported in quantities required for use in Pakistan during 1976 in agreement with the PNCB:
Cocaine ........................................................12 kg
Codeine ..............................................................6415 kg
Diphenoxylate .........................................................43 kg
Ethylmorphine .........................................................12 kg
Methadone ...............................................................7 kg
Morphine ..............................................................110 kg
Opium (in addition to the opium grow locally)....... 4000 kg (for quasi-medical use)
Pethidine ...............................................................160 kg
Pholcodine ..............................................................57 kg
It may also be mentioned that the PNCB has an understanding with the National Health Laboratories at Islamabad for analysis of drugs, both for enforcement work as well as for the diagnosis of drug-dependent persons.
(c) Cultivation of medicinal plants as a substitution for Papaver somniferum
The Pakistan Forest Institute located at Peshawar was visited in order to determine the feasibility of cultivating medicinal herbs in substitution for opium. The Director-General of the Institute (Dr G. M. Khattak) expressed the view that prior to the initiation of any project aimed at the development of medicinal herbs, it was essential to seek the view of the pharmaceutical industry and other smallscale manufacturers regarding the need for such medicinal herbs. Particular interest was expressed in the following plants:
Dioscorea, from which diosgenin is obtained; this is the principal ingredient of oral contraceptive pills based on plant products. There is a very large demand for these pills for the Population Planning Programme in Pakistan. Dioscorea has been grown experimentally in Kaghan, Abbottabad and Dunga Gali. The Population Planning Department is very interested in this project in view of the world-wide shortage of diosgenin. There appears to be scope for further research with regard to this plant.
Papaver bracteatum, which the Director-General of the Institute and the medicinal-plant botanist (Mr Anwar Ahmed Khan) consider could grow well in Pakistan. Unfortunately, the seed which was obtained from Iran proved to be of poor quality. However, tests arc now being conducted with seeds obtained from the United Nations Narcotics Laboratory in Geneva.
Artemesia, 4 a plant which grows on a reasonably wide scale in the Kurrum Agency, is currently being processed at the Kurrum Chemical Factory located in Rawalpindi. Research on the efficacy and toxicity of santonin has been carried out by administering it to children suffering from round-worm infections. Discussions are now under way on how to improve the santonin yield of these plants. It is envisaged that there may be further research at the Forest Institute, in collaboration with the North Regional Laboratory of the Pakistan Council for Scientific and Industrial Research (PCSIR) in Peshawar and the Khyber Medical College, also located in Peshawar.
Pyrethrum, which has been grown on an experimental basis at the PCSIR laboratory, has the potential to grow well in the highlands of the NWFP. Limited experiments have already been conducted by the PNCB in their project area (located in Buner and Hazara districts). The PNCB have also concluded an informal agreement with the PCSIR to assist in future experiments with this plant in certain areas of Buner, Hazara and Kurrum Agency. The Kurrum Chemicals company have indicated their interest in buying up to 400 tons of Pyrethrum seeds.
For further information concerning this plant, see Khan I., "Pharmaceutical Industry and Local Raw Materials in Pakistan", Finance and Industry (Pakistan), December 1968, pp. 13-17, and I. Khan et al. "Evaluation of relative efficacy and toxicity of santonin and piperazine in human ascariasis", Journal of the Pakistan Medical Association, Vol. XX: 5, pp. 137-147, May 1970.
It is generally agreed that doctors, pharmacists, nurses, dentists, and other members of the health profession must be informed of the essential aspects of drug abuse control relevant to their particular profession, with particular reference to chemistry, animal pharmacology, clinical pharmacology, epidemiology, drug abuse control, etc. At the present time, the existing curricula do not appear to include adequate information on these subjects and more instruction must be provided in many countries. In most cases the medical profession in Pakistan is not fully concerned about the drug abuse problem, or considers these problems to be rather insignificant both as regards their extent and the hazards to the community. Moreover, the result is that the medical profession is largely unaware of the new techniques of diagnosis, treatment or prophylaxis in the field of drug abuse. The necessity of carrying out in-depth studies of the lacunae in medical education is, therefore, obvious. In the authors' view, the responsibility for carrying out such a study should be assigned to a specialist with appropriate qualifications and a suitable background who might later establish co-ordination with the universities, medical institutions, dental and pharmacy institutions, the Medical Council of Pakistan, the Nursing Council of Pakistan, the Pharmacy Council of Pakistan and the Pakistan College of Surgeons and Physicians, and develop mechanisms for the implementation of recommendations in this regard.
Though national priorities and scarcity of resources have been limiting factors, the drug problem did not escape attention in the past. The Commission for the Eradication of Social Evils, constituted by the Government to examine the nature and origin of social customs and practices which produced ill-health or were economically oppressive, proposed in its 1964 report that the consumption of intoxicants like "wines and drugs with dependence liability" should be kept in view as areas for further investigation.
In a message to the First National Workshop on the Prevention and Control of Drug Abuse held in Pakistan in August 1975, the Prime Minister stated that "drug abuse tends to threaten the younger generation and thus to consume the flower of our youth. Experts in the Workshop will, I hope, analyse the problem in its total perspective and devise a scientific strategy to protect and save potential victims from this menace. The Government of Pakistan cannot countenance this wasteful degenerating drain on the nation's human resources." In his message to the same conference, the Federal Minister of Health, Social Welfare and Labour made the following statement: "The narcotics problem is extremely complex since it affects various aspects of human activity but basically it arrives from misuses of drugs and thus needs to be tackled amongst other sectors especially in the sphere of public health... It is the responsibility of the medical profession to apply itself selflessly and wholeheartedly to evolving workable programmes for treatment and rehabilitation of addicts."
In an editorial note entitled "Drug Addiction in Pakistan", appearing in the June 1965 issue of the Journal of the Pakistan Medical Association, one of us (I.K.) pointed to the need for rationalization of drugs with dependence liability especially in the Province then known as West Pakistan. He also drew attention to a resolution adopted in 1964 by the General Assembly of the All-Pakistan Medical Association in support of his assertion which stated that "the Pakistan Medical Association strongly objects to the unrestricted sale of pethidine and morphine in certain parts of West Pakistan. It has resulted in a large increase of addiction especially in young people. Rationalization of these drugs should be done."
The authors would like to express their thanks to the following persons in Pakistan for contributing their valuable time to hold discussions on various aspects of drug abuse in the country:
Mr. Raoof Ali, Chairman, Pakistan Narcotics Control Board, and Secretary to the Government of Pakistan, Islamabad.
Professor Nasir A. Sheikh, Director-General Health, and Additional secretary, Government of Pakistan, Islamabad.
Brig. S. M. Yusouf, Secretary of Health, Government of NWFP, Peshawar.
Dr. Awni Arif, WHO Representative, Islamabad.
Mr. J. Gammelgaard, Co-ordinator UN, Islamabad.
Mr. Fazal Ellahi Siddiqui, Regional Directorate, Pakistan Narcotics Control Board, Peshawar.
Dr. Nazir-u-Haq, Deputy Secretary (Health), Health Secretariat, Peshawar, and his colleagues, Dr. Sardar Ali and Dr. Rafi-ud-Din.
Sh. Mohammad Hussain and Sons, chemists and druggists in the NWFP.
Professor Ashfaq Ahmad (Department of Pediatrics), Professor Sirajud Din Ahmad (Department of Medicine), Dr. A. Ghaffer (Clinical Pharmacologist), and their colleagues at the Government Lady Reading Hospital, Peshawar.
Mr. Alan, Social Worker, Mission Hospital, Peshawar.
Dr. Riaz Ali Shah and his colleagues at the North Regional Laboratory, Pakistan Council of Scientific and Industrial Research, Peshawar.
Dr. M. Shafique, Mental Hospital, Peshawar.
Mr. Najab Khan, Assistant Director, Excise and Taxation, Directorate of Excise and Taxation.
Dr. Amir Ghawas, Madyan Civil Hospital, Swat.
Dr. Mian Said Wahid, District Health Officer, Swat.
Mr. Abdul Rashid Khan, Village Shookh Darrah, Teh: Matta, Swat District.
Dr. Abdul Ghafoor and his colleagues at the Civil Hospital, Malakand.
Dr. Shah Wazir, Pacha Civil Hospital at Pir Baba (Buner), Swat.
Dr. Mukhtar Ahmed, Chamla Hospital at Nawagai (Buner), Swat.
Dr. Mushtaq and Dr. Mazharul Haq, Central Government Hospital, Rawalpindi.
Dr. S. Amanat Shah, Civil Hospital, Nathia-gali, Hazara District.
Dr. G. M. Khattak, Director-General, Pakistan Forest Institute, Peshawar.
Dr. Hakim Khan and his colleagues, District Hospital, Abbotabad.
Mazhar Hussain, Social Science Research Centre, University of the Punjab, Lahore.
Haji Dr. Mohd Yunus, Chairman; Mr. Hidayat Ullah Khan, Secretary, Society for the Prevention of Drug Abuse in NWFP.
Dr. S. Haroon Ahmed, Assistant Professor of Psychiatry, Jinnay Postgraduate Medical Centre, Karachi.
Dr. Inam ul Haq, National Health Laboratories, Islamabad.
Mr. S. M. Nawab, Regional Director and Mr. Khalid Hussain Pathan, PNCB, Karachi.
Mr. Abdul Razzak Patel, Laboratory of Chemical Examiner, Customs, Central Government, PECHS, Karachi.
Dr. Khuwaja Moinuddin and office-bearers of the Pakistan Medical Association, Karachi Branch.
Dr. Ali Muhammad Ansari, Secretary, Health and Social Welfare, Government of Sind, and his colleagues.
Professor Mohammad Yunis Khan, Director, and his colleagues at Jinnah Postgraduate Medical Centre, Karchi.
Dr. Subhan Khan, Director, and Professor S. M. K. Wasti, Pakistan College of Physicians and Surgeons.
Dr. S. A. Raza, Principal Khyber Medical College, Peshawar.
Finally, the authors would like to express their thanks to Mr. S. S. Fluss, Senior Editor, International Digest of Health Legislation (with whom the senior author shares a common alma mater, Edinburgh University, and an interest in drug abuse legislation), for his editorial assistance in the preparation of this paper. They would also like to express their gratitude to Mrs. Lesley Wulf for her unfailing patience and enthusiasm in typing the manuscript.
