This discussion note is based on one of the chapters of the book entitled, “The Truth Pill” authored by Dinesh Singh Thakur and Prashant Reddy Thikkavarapu. The book came out in the year 2022 and is a classic, timely, well-researched work highlighting the importance of safety and quality of drugs in Indian Pharmaceutical Industry. Now when India is the Largest growing pharma industry in the world the question of drugs efficacy, quality, duplicity, and pricing is more important than ever.
The debate over regulations, sales, quality, manufacturing of drugs is not new to India. The point here in question is about the drugs import practices to India during colonial period and the newly growing market of domestically manufactured drugs. India at that time was known as a market of British finish products including medicines and India was a hub of raw materials.
John Sullivan, a revenue officer during Colonial India quoted, “Our system acts very much like a sponge, drawing up all the good things from the bank of Ganges and squeezing them down on the bank of Thames.”
In that time India was the dumping ground of any kind of adulterated drug and hub of quacks medicines poured in from every part of the world. There was no uniform law regulating the manufactured drugs. Some of the provincial states like Bengal, Assam, The Central Provinces, Ajmer, and the United Provinces had their separate provincial legislations to regulate the sale of adulterated drugs but they didn’t focus on the drug quality and their efficacy. However, simultaneously in Britain, there were two acts namely: The Sale of Food and Drugs Act 1875 and the therapeutics Substance Act, 1925 for the local regulation of drugs.
It dated back to the year 1927 when Sir Haroon Jaffer, a legislator from the Bombay Presidency had questioned the regulation of sale and manufacturing of pharmaceutical drugs and the need of standardization. Sir Jaffer pointed out four major concerns namely:
- In India there was an indiscriminate availability and efficacy of all drugs and how it is a money-making formula for the manufacturers.
- Doctors and their prescribed drugs: Doctors in general prescribe of what is known as the patent and the proprietary drugs which includes secret remedies. Secret remedies refers to, when the ingredients of the medicines are not disclosed in public domain.
- There was a high demand of all kinds of powders, serums, vaccines despite of weird and absurd advertisements made by the manufacturers.
- Further, there was of adulteration and sub standardization of drugs. Number of quacks and unqualified doctors practicing in India were also high.
Among the supporters of the resolution, there were some who questioned Sir Jaffer’s criticism of doctors. To name one was Dr. U. Rama Rau, she claimed the reasons why patent medicines are such a hit among consumers is because of the advertisings and less because of doctors. Thus, to criticize the move to publish advertisements of patent medicines in newspapers it moved towards questioning the doctors instead.
Second criticism was that Sir Jaffrey’s resolution resulted in more affirmation towards western medicines and not Indian medicines. Hence, these objections, resulted in dropping of the claim made by Sir Jaffer as “craze of medicinal drugs” to “indiscriminate use of medicinal drugs” in India.
Earlier in colonial times, the prime idea behind drug regulation is to control trade in narcotics and taxation. That means, the government labs were mainly responsible to check the amount of alcohol and opium in food and drug products to determine the excise duty payable and not to check the drug adulteration or drug quality from the safety angle. However, this legislation has changes eyes and ears of British ruled India. Another issue was British also had a very little incentive to create a good regulatory framework to regulate the import of medicines coming from their own mother land.
Quinine Fraud in medicines
After Sir Jaffery’s resolution being adopted by the council of states, In 1928 another issue came in known as “Quinine Fraud” raised by Lt. Colonel H.A.J Gidney. This issue came in after India was suffering from Malaria with over 4 million patients a year. In all, quinine was a major issue. In his words " the most terrible fraud that has ever been perpetrated on this country and the unrestricted sale of this spurious drug has, I submit, been largely responsible for the steady high mortality from Malaria”. But again, this move was down from the British Government side.
Media and News
Medical Journals like Indian Medical Gazette, The Indian and eastern Druggist, and the Pharmaceuticals Journal of England, etc. raised a support of government regulation of drugs. Another reason for the delay in setting up of a regulatory framework law in India was Government of India Act 1919 where it devolved legislating powers from Indian legislature to various provincial legislatures. Medicines was and is a transferred subject and the imports fall within the purview of GOI and the Indian Legislators.
What Gidney suggested that regulation of imports could result in quality of drugs in a positive way as most drugs in India (colonial) were not manufactured but imported from UK.
The Chopra Committee, 1930-1931
In 1930, an expert committee was formed after consulting with provincial governments and its people to learn and analyze the loop hole in the quality of Indian drugs and medicines that were being sold in India.
This committee was headed by Lt Col. R. N. Chopra (Father on India Pharmacology), member of IMS and Professor at the School of Tropical Medicine. The extent of purview of the Chopra Committee was based on long extensive consultations where they analysed 638 questionaries collected from different medicines professionals, medical journals, pharmacists, govt bodies, etc. The results from the survey were mind boggling. It was found that Quinine pills that were being sold contained more clay and chalk. The cheap quality of drugs which were widespread contain worthless medicinal agents. Like Quinine, other drugs namely santoninm and cinchona were also heavily adulterated. This way India was crying out loud for a strong legislation to stop adulterated drugs in India like the Therapeutic Substance Act of The United kingdom.
Opposition from The Indian Medical Association
However, there was one strong criticism from Indian Medical Association on establishing this legislation as it somehow affect the growing India pharmaceutical industry and they were opposed the fact that inferior drugs were being sold in India. They also claimed that in that committee there were only representatives of the British firm and no single Indian firm were given any representation.
After all this, a final report came in 1931 that drug control legislation must be enacted in India. To increase the pace of reform the Indian Penal Code made provisions for penalising firms for selling adulterated drugs. Some of the reasons for the delay were lack of standardisation of drugs, lack of funds for testing of drugs in labs, lack of cooperation between different provinces.
Imports of Drugs Bill
Only after all the delays and problems, in 1937 the Imports of Drugs Bill introduced in the legislative Assembly to control the imported drugs in India. However, domestically manufactured drugs were again left behind. This bill again was rejected and a new strategy was adopted to create a uniform legislation across British India to control domestically manufactured drugs. This strategy led to form the Drug Act of 1940 which had separated both the powers of federal and provincial government to have their own pharmacopeial standards to avoid any confusion. Pharmacopeial standards means different methods of testing drugs purity and effectiveness. Further, this law also let the provincial government to play with their on hiring policies, licensing and labelling of drugs. Federal government on the other hand could also make rules for import of various drugs. However, again to stop the confusion and maintain an uniform work pace two law bodies were created namely the Drug technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
Still the law was left with many unanswered questions like clinical proof regarding the safety of drugs, lack of regulation on Indian medicines (unani and ayurveda), control of false advertisements claiming the superiority of few drugs and most importantly nexus of pharma industry and medical professionals.
It is sad to note that some of these issue are still persistent in the 21stCentury. No matter India has become the leader of Pharma world, there are questions on the credibility of generic and substandard drugs. Quality of drugs and its regulation is not evolving to full of its strength and this impacts health of millions who import drugs from India.
Thakur, D.S. and T., R.P. (2022) Truth Pill: The myth of drug regulation in India. New Delhi: Simon & Schuster India.