Drug Legislation in India by Gaurav Kumar Sharma

History of Drug Legislation in India

During 1920-1930 there were number of reports of harmful substitutes and adulterants being marketed in place of genuine drugs and toxic effects of such drugs were published in Indian press from time to time. According to reports of Indian Medical Gazette during this period, there was absolutely no control over the manufacturing, sale and distribution of drugs in India. Several deaths were reported due to spurious drugs. In place of eye drops, croton oil was used. Chalk powder was frequently found to be used for adulteration of drug formulations. There were toxicity reports due to overdose of mercury compounds. In the absence of effective Acts and Rules related to drugs and pharmaceuticals in the country, there was a rat race for manufacturing of sub-standard, spurious and adulterated formulations.

 As a result of alarming adverse reports, deaths due to spurious and adulterated drugs and in view of protests within and outside the country concerned with poor medical facilities offered by British rulers in India finally, on 9th March, 1927, The British Government was forced to initiate action for drug legislations. The Council of State in British India headed by the Viceroy passed a resolution to counter or check malpractices in drug dispensation and medication. On 11th August, 1930, Drugs Enquiry Committee (D.E.C.) was constituted under the Chairmanship of Col. R. N. Chopra which was a historic development signalling beginning of new era of drug legislation in our country. Prior to the constitution of this Committee, there was no significant piece of legislation regulating the import, manufacture, sale and distribution of medicine. No Act was in vogue prescribing qualification of a pharmacist and there was no systematic procedure adopted for registration as pharmacists.

 Important Milestones in Drug Legislations and Pharmacy Profession (Education, Practice, and Industry)

PRE-INDEPENDENCE ERA

1664-The first hospital was opened at Fort St. George, Madras.

1811- Young Scotch named Mr. Bathgate came to India with East India Company and opened Chemist's shop in Calcutta.

 1820- Lord Cornwallis started Opium factory at Ghazipur (U.P.).

1824- Hindustani versions (Devnagri and persion scripts) of the London Pharmacopoeia were prescribed.

1824 -The East India Company decided to impart knowledge of medical science-both European and Indian.

1835- First two medical colleges established at calcutta and Madras.

 1857- Few sections of lndian Penal Code were applicable for drugs.

 1857, 1878 The Opium Act enacted.

 1860- The beginning of pharmaceutical instructions in British India at Madras Medical College.

1868- The Pharmacopoeia of India published under the authority of Secretary of State for India.

 1885- British Pharmacopoeia was made the sole authority for pharmacy profession.

1889 -The Indian Merchandi~e Marks Act enacted.

 1894- The Indian Tariff Act enacted.

1898- The Sea Customs Act enacted.

1899 -The Compounders training course started in Madras.

1899 -Achary P.c. Roy along with Kartic Chandra Bose established Bengal Chemical and Pharmaceutical Works at Calcutta.

1905- Gajjar and Co. established at Bombay which also started drug manufacturing.

1906 -In U.S.A. - Federal Food & Drugs Act introduced.

 1919- The Poisons Act enacted.

1920- All India Compounders and Dispensers Association was established.

1920- In Canada - Food and Drugs Act introduced.

 1924- The Cantonment Act enacted.

1925 -In U.K. - The Therapeutic Substance Act introduced.

 9-3-1927- Resolution of Council of States in India regarding health services.

 1928- In U.K. Drug Adulteration Act enacted.

1928 -The state medical faculty of Bengal introduced two years course for compounders.

11-8-1930 -Drugs Enquiry Committee (D.E.C.) headed by Col. R. N. Chopra constituted.

1931-Report submitted by D.E.C. to Central Government.

1932 -A two year Degree Course in Pharmaceutical Chemistry for B.Sc. - Beginning of pharmacy education at Banaras Hindu University by Prof. Mahadev Lal Schroff (Father of Pharmacy Education in country).

 1-11-1933- The Indian Medical Council Act enacted.

 1935 -United Provinces Pharmaceutical Association (UPPA) established at Banaras by Prof. Mahadev Lal Schroff.

1937- Import of Drugs Bill introduced in the Parli~ment (British India) and later withdrawn due to criticism.

1937 -Biological Standardization Laboratory (B.S.L.) established at Calcutta.

1939 -United Provinces Pharmaceutical Association (U.P.P.A) was renamed as Indian Pharmaceutical Association (I.P.A). Publication ofIndian Journal of pharmacy started.

1940- Drugs Bill introduced in the Parliament and Drugs Act later amended to Drugs & Cosmetic Act (D.C.A) was enacted.

 1940 -Biological Standardization Laboratory was named as Central Drugs Laboratory (COL) under DCA.

 1941 -First Drugs Technical Advisory Board (DTAB) constituted.

1941- First All India Pharmaceutical Conference was held at B.H.U, Varanasi under the Presidentship of Prof. Mahadev Lal Schroff.

 1943- Health Survey and Development Committee constituted under the chairmanship of Sir Justice Joseph Bhore.

1944- First I. P. Committee constituted.

1945 -Pharmacy Bill introduced in the Parliament.

1945- Justice Joseph Bhore submitted report.

1945- Rules for Drugs & Cosmetic Act framed.

1946 -Indian Pharmaceutical Codex (I.P.C) published.

POST-INDEPENDENCE ERA

1947- The Indian Nursing Council Act enacted.

 1948- The Pharmacy Act, 1948 enacted.

 1948 -The Dentists Act, 1948 enacted.

 9-11-1949- First 'Pharmacy Council OJ India' (P.C.I.) constituted under the Pharmacy Act.

 1949 -Dr. K.C.K.E. Raja was nominated by the Central Government as the first President of Pharmacy Council of india.

 1951- The Industries Act enacted.

11-7-1953 -First Education Regulations (E.R) as approved by the Ministry of Health & F.W., Government ofindia were notified.

1954- The Drugs and Magic Remedies (Objectionable Advertisements) Act enacted.

 1954- The Pharmaceutical Enquiry Committee recommended appointment of graduates in Pharmacy as Chief Pharmacists for all large hospitals.

1954- The first B. Pharmacy Course approved by Pharmacy Council ofindia at Birla College, Pilani.

1955- The first Diploma in Pharmacy Course approved by P.C.I. at Government Medical College, Amritsar.

1955 -First Indian Pharmacopoeia published.

1955- The Medicinal and Toilet Preparations (Excise Duties) Act.

1956 -Essential Commodities Act enacted.

1956 -The University Grants Commission Act enacted.

1957 -Dangerous Drugs (Import, Export & Transhipment) Rules framed.

 1960- Prevention of Cruelty to Animals Act passed.

1960-70 -Indian Drugs & Pharmaceuticals Ltd. (I.D.P.L.) established at five places in the country.

1962- The Central Manufactured Drugs Rules framed.

1962- Beginning of National Pharmacy week celebrations in third week of November every year.

1963- Pharma Times Publication of I.P.A as professional monthly publication.

 1963- The Indian Hospitals Pharmacists Association (IHPA) was launched at Pilani, Rajasthan.

 1964- The Indian Journal of Hospitals Pharmacy was started by Prof. B.D. Miglani for IHPA.

1966 -Second Indian Pharmacopoeia published.

 1968 -Insecticides Act enacted.

 1970 -First DPCO (Drugs Price Control Order), Later on in 1979 and 1987, 1995 published.

1970- Indian Patents Act enacted.

1971- Medicinal Termination of Pregnancy Act enacted.

1972 -Education Regulations of P.C.I. 1972 (notified on 6-1-1973).

1973 -Homoeopathy Central Council Act enacted.

 1974 -Committee of M.P.s with Jaisukhlal Hathi as chairman for drugs and pharmaceuticals constituted.

1975- Hathi Committee Report Submitted. The Committee recommended that a Chief Pharmacist with atleast a graduate in pharmacy degree should be appointed for maintaining quality of drugs supplied to patients in hospitals.

1975- All India Organisation of Chemists and Druggists (AIOCD) established with Mr. VL. Theagaraj as President.

1976- The Dentists (Code of Ethics) Regulations framed.

1977 -Indian Pharmaceutical Congress along with Conference of Commonwealth Pharmaceutical Association was held under the Presidentship of Dr. J.N. Banerjee at Mumbai.

1978- Drug Policy was announced based on Hathi Committee report.

1979 -Indian Journal of pharmacy was named as Indian Journal of Pharmaceutical Sciences (Bi-monthly publication).

1981- Education Regulations ofP.C.I. notified on 11.7.1992.

1985 -Third Indian Pharmacopoeia published.

1985 -The Narcotic-Drugs & Psychotropic Substances Act enacted.

1986 -Consumer Protection Act enacted.

 1986- Revised Drug Policy was announced.

23-12-1987- The All India Council for Technical Education (AICTE) Act covering pharmacy education enacted.

1989 -Golden Jubilee of Indian Pharmaceutical Association celebrated.

 1991- Education Regulations ofP.C.1. notified in 1993.

 1994 -Modifications in Drug Policy, 1994.

1996- Hon. Supreme Court directed Government to come out with National Policy on Blood Programme. Subsequently, National Blood Policy of NACO (National AIDS Control Organization) brought out.

1998- Golden Jubilee of Indian Pharmaceutical Congress alongwith Conference of Federation of Asian Pharmaceutical Association (FAPA) was held at Mumbai under the presidentship of Prof. C.K. Kokate.

1999 -Golden Jubilee Year of Pharmacy Council ofIndia celebrated throughout the country.

 2001 -The first pharmacist (Prof. C.K. Kokate) appointed as Vice-Chancellor ofIndian University, (Kakatiya University A.P.).

2002- Pharmaceutical Policy announced by Ministry of Chemicals and Fertilizers, Department of Chemicals.

2005- In Post-WTO era, new patent regime (Product Patent) has started.

Drugs Enquiry Committee (D.E.C.), 1930

 It was constituted in 1930 with Col. R.N. Chopra as Chairman, Shri C. Govindan Nair as Secretary and Dr. B. Mukherjee as Assistant Secretary. The other three members of the Committee were Fr.J .F. Caius, Mr. H. Cooper and Maulvi Abdul Matin Chowdhary. The Committee did splendid service to the cause of pharmacy profession in the country. The Committee visited many places in the country and interacted with the doctors and other professionals on the matters pertaining to health care system in country, quality of medicines available, etc. The questionnaires were sent by the Committee to medical personnel, customs officers, manufactures, medical associations and others related to medical field.

The terms of references for the Committee were as follows:

 1. To probe into the quality of drugs, that are being imported, manufactured and sold especially, those which are official in B.P.

2. To suggest remedial measures for checking import, manufacturing, sale or distribution of the substandard or spurious drugs and their formulations.

 3. To look into the formulations prepared indigenously from the vegetable drugs and suggest remedial measures for maintaining the quality of such formulations.

4. To look into all other aspects directly or indirectly connected with the profession of pharmacy.

        D.E.C. reported that there was no systematic profession like pharmacy being practiced in the country. The drugs were dispensed and compounded or handled mostly by the untrained people. The remuneration paid to them was poor. The so-called compounders with no knowledge of drugs were handling the drug formulations. They were also doing the work of dressers, helpers, laboratory technicians and all other miscellaneous jobs including, maintaining the accounts of doctors. These compounders were able to read and write in English and that was the only qualification they had for handling the drugs. Only in the provinces of Bengal and Madras, there was a training course for compounders/ chemists & druggists. The report was a sad commentary on the poor state of the profession of pharmacy in the country. After in-depth study and critical analysis, the committee made following recommendations to the Government:

 1. There should be legislations to control drugs and other remedies whether belonging to the B.P or not.

2. There could be another law to ensure that drugs are handled by qualified persons and there could be a systematic course in pharmacy.

3. A drug regulating authority at center and in provinces/states be established.

 4. There should be drug/quality control laboratories established in provinces and also at the centre. The efforts should be made to publish Indian Pharmacopoeia.

The Committee submitted its report in 1931. The findings of the Committee spurred activity in teaching institutions, industry and the profession. Uhtil 1937, British rulers did not act on this report. In 1937, Import of Drugs Bill was introduced with limited reference to the import and later withdrawn due to public criticism. Finally, in 1940 The Drugs Bill was introduced in the Parliament, based on the recommendation of D.E.C and after in-depth deliberations The Drugs Act, 1940 was enacted which was latter ammended to the Drugs and Cosmetics Act, 1940.

The Health Survey and Development Committee, 1945 constituted under the Chairmanship of Justice Bhore also re-emphasized the need for the qualified and trained pharmacists and registration of pharmacists, formation of Councils to govern the profession at Centre and in Provinces, strengthening of the provisions of Drugs Act, more drug control laboratories for strengthening of infrastructure for drug regulation, etc.

The recommendations of Drugs Enquiry Committee and Health Survey and Development Committee were responsible for laying the foundation for the Pharmacy Act, 1948. The Pharmacy Council ofIndia was constituted in 1949 and the minimum qualification for registration as pharmacist was prescribed and process for registration described.

After independence, it was felt to regulate the advertisements of drugs, which were in exaggerated form and misleading. A number of manufacturers were making exaggerated claims for their medicines and also exploiting the human weaknesses especially, in relation with advertisements pertaining to sexually transmitted diseases, menstrual disorders, loss of vigour, stamina, etc. The magic remedies were freely advertised for the cure of Bhanamati, epilepsy or fits, diabetes and number of other diseases. The magic remedies in the form of Kavachas, Taits, Talisman, Sacred Bones, Sacred Bhasmas, Mantras, etc., were freely practiced and the poor and illiterate people were exploited. It is to control such objectionable trends, "The Drugs & Magic Remedies (Objectionable Advertisements) Act" was passed by the Parliament in 1994.

Alcohol is an important solvent in pharmaceutical industry. Alcohol is required for manufacturing of drugs and also for drug formulations as vehicle, preservative and therapeutic agent. At the time of independence, manufacturing, sale and distribution of alcohol was controlled by provinces/states. The rates charged by the provinces/states in the form of excise duties were different for different regions. Alcohol was also being misused and it was drug of abuse. It is to regulate the production, sale and distribution of alcohol and to bring uniformity in the excise duties to be paid, the Medicinal and Toilet preparations (Excise Duties) Act was passed by the Parliament in 1955.

 The Drugs Price Control Order, 1970 and thereafter at subsequent intervals was aimed at fixing the prices for the drugs and their formulations categorized into essential and non-essential groups so that uniform retail rates for certain categories of drugs can be maintained and the drugs prices of life saving drugs can be controlled.

The Indian Patents Act 1970 which was process patent based gave an impetus to Indian pharmaceutical industry which resulted increased indigenous production of drugs and pharmaceuticals. In post WTO era, with the new product patent regime coming into force, the Indian pharmaceutical industry is undergoing rapid metamorphosis to meet the challenges of globalization of pharmaceutical trade. Many Indian pharmaceutical companies have acquired the status of multinational companies. A new era of pharmaceutical profession in India has just begun to meet the challenges of Post-GATT and Post-GATS developments.