Till independence in 1947, India has been following or rather copy-pasting the British regulations, whether in the Drugs Act, 1940, the (Indian) Patents and Designs Act, 1911 or the Medicinal and Toilet Preparations Act, 1955 (which emerged from Prohibition Act and Narcotic Act). Even though the Drugs Act was passed by the Indian Parliament in 1940 and the Drug Rules became official in 1945, the effective implementation commenced only many years later, after independence in 1947. Most Indian companies were manufacturing extracts, tinctures and medicines which were ‘compounded’ in the Medical Practitioner’s clinic. The Drugs Act, 1940 was later amended to include cosmetics in late 60s and further amended to include Ayurvedic preparations in the 80s. The Indian drug laws and its administration is in the Concurrent List (There are three lists, Union list, State list and Concurrent List), this made the uniform implementation of the Drugs & Cosmetics Act, a big challenge in India. Even though, the Act and Rules for drug formulations were already in place during independence, the enforcement was extremely weak and slow in implementation. Drugs Control Administrations were set-up in or around 1955 to 1957 in Bombay State (Maharashtra and Gujarat), Mysore State (Karnataka) and Madras Presidency/ State etc.
Pharmacy Act, 1948 was the most important legislation post-independence. BV Patel, Drugs Controller of the Bombay province, ML Khorana, UDCT and KG Ananthanarayan, Haffkine Institute constituted the first pharmacy tribunal to formulate the pharmacy regulations. After Pharmacy Council of India and various State Pharmacy Councils were formed in the 1950s and 1960s, consequent to the linguistic division, the states of Maharashtra and Gujarat were born in 1960. Patel was transferred as the Director of Drugs Control in Gujarat and Dr MK Rangnekar became the Director of Maharashtra Drugs Administration. The states of Karnataka and Madras were born too. It is around this time that the implementation or enforcement of Drugs and Cosmetics Act, commenced in India. While the pharmaceutical industry in India was ‘formally’ born in West Bengal (during the days of Acharya PC Ray), with pharma companies such as Dr Paul Lohmann, Bengal Chemical, Bengal Immunity, Smith Stanistreet, Dey’s Medical and others. Bombay (Maharashtra) and Gujarat emerged as pharma pioneers during 1960 to 1970 period. While Haffkine Institute (vaccines) and Cipla were industry leaders in Bombay, Alembic, Sarabhai and Gujarat Pharmaceuticals took lead in pharma industry growth in the western region. It is noteworthy that the hand-holding, industry-friendly, problem solution approach of industries in Maharashtra and Gujarat helped the growth of pharma industry in western India. The role of Central Drugs Standard Control Organization (CDSCO) or the office of the Drugs Controller (India) in Delhi remained restricted to law making till the 1990s. Central Drugs Controller’s approaches being friendly to industry and State Drugs Control [later named as FDAs (Food and Drugs Administration], there were harmonious growth of the pharma industry in India, in spite of the ‘Concurrent Status.’
Amendments
Major amendments to the Drugs and Cosmetics Act, 1940 were incorporated over the years including Schedule M, Schedule Y etc. In early years, it was the regulators who used to take a lead in resolving quality related problems of the industry. For example, the ‘particulate matter’ in injections was a perennial problem which needed technical and technological solutions. The Drugs Administration under Dr Rangnekar, took the lead jointly with industry and professional associations like Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Association (IPA) to conduct extensive workshops and lectures by experts (including overseas speakers) to resolve the problem, which was eventually eliminated completely. Regulatory agencies working closely in tandem with the industry, catalytically promotes the healthy quality growth of the industry. While we have come a long way as regards to the quality of the regulators at CDSCO/DCG(I) office, the non-uniformity at the state level of FDAs in the country is alarming. While the state level drugs control officers have formed an association, ‘The All India Drugs Control Officers’ Confederation (AIDCOC) and have open...
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