Getting pharma regulation right should be top priority

Subir Roy

Senior Economic Analyst

A government inspection of quality control in the Indian pharmaceutical industry, conducted by the Central Drugs Standard Control Organisation, has corroborated some of the darkest observations made by critics in the wake of children in the Gambia and Uzbekistan dying last year after consuming India-made cough syrups. It is through this exercise that regulators have come to know the ground reality, which they should have been aware of long ago and taken mitigating steps to avert the crises that have been unfolding.

The shortcomings revealed include the lack of a quality culture, disregard for maintaining quality integrity and insufficient training. These have led to a high rate of production of non-standard quality drugs, a euphemism for substandard stuff.

Although remedial action is yet to take place, the investigation has already had a salutary effect. Central and state regulators now are on the same wavelength about what needs to be done to set things right. A bane of pharma quality control in India, highlighted by critics in the past, is the multiplicity of regulators. There are central and state regulators, who have been often working at cross purposes. The domestic manufacture of most drugs is licensed by state drug regulators and not the central regulator. Hence, the quality of most medicines varies widely across states.

A well-regulated pharma industry is essential. We cannot live longer and have better quality of life without the support of modern medicine. Plus, the pharma industry has been particularly important for India because of historical and current economic reasons. The Indian pharma industry is seen as a kind of pharmacy to the world, a source of affordable generic (off patent) medicines. It has played a historic role in producing HIV drugs which have saved innumerable lives. In large part, affordable healthcare across the world, significantly in the US, too, would not have been deliverable without generic medicines produced by Indian companies.

The historical credit for this goes to the Indira Gandhi-led government (in the early 1970s), which kept product patents out of India while abiding by process patents. This allowed India to produce costly medicines still under patent in the West by devising alternative processes with its chemistry skills. As a result, India is the third largest pharmaceutical producer in the world today in terms of volume and the 14th in terms of value. The industry is valued at $50 billion, with exports earning $25 billion. It supplies 60 per cent of the global vaccine demand, 40 per cent of the generic demand in the US, and 25 per cent of all medicines in the UK.

In this scenario, it is imperative that no one should have any doubt about the quality of medicines produced here. It was this confidence which was shaken by the Gambian children’s deaths. Things were made worse by accusations which followed from Uzbekistan, Sri Lanka and even the US that Indian drugs were causing not just blindness but death, too.

There is now clarity as to where action needs to be taken. Drug companies often lack qualified personnel and equipment to conduct proper tests to identify the presence of adulterants. It is the likely presence of an adulterant, diethylene glycol, which caused blindness.

One action that did no good was the Ministry of Commerce’s order, in the wake of the tragedies and allegations, that all cough syrups meant for exports be first tested at government-run laboratories. Not only is the ministry not the appropriate authority in pharma matters, but it also raised the question of how we could be sure that similarly adulterated cough syrups were not harming Indian patients. This is what happened in Jammu, where 12 children died after consuming adulterated cough syrup between December 2019 and January 2020.

What should not be done was highlighted by a new law proposed last year, the Drugs, Medical Devices and Cosmetics Bill, 2023, to replace the Drugs and Cosmetics Act, 1940, which did not address some burning issues that have now been raised. A new law that needs to be brought in should centralise the licensing function to ensure that drug regulation is the same across the country. Right now, there are 28 state drug regulators, a national drug regulator and two statutory bodies advising the national regulator.

Also, the nature of the drug controller’s office needs to change. It should do what an internal exercise of the government itself has recommended: that the drug controller be made an independent statutory authority, like securities regulator SEBI and food safety regulator FSSAI. This will give the regulator independent authority to do things, like hire experts without ministerial approval.

Adverse developments have already started taking place. The US is taking serious steps to onshore pharmaceutical manufacturing after becoming exasperated with its long experience of issuing ineffective quality warnings to Indian manufacturers. Some African nations are also thinking on similar lines.

Another idea which needs to be put into practice right away is to create a common information technology platform which can become a reference point for every kind of information — past data as well as current developments — which the industry, regulatory bodies and focused non-government entities can use to go about their work effectively. This should not be difficult, given what India has done to create a public infrastructure for online governance.

Perhaps, the best thing that has happened is that the minister concerned has asked that the process of setting right pharma regulation be conducted in “a spirit of cooperative federalism”. If this happens, all will be able to build on each other's strengths and remove the drawbacks in the system. That this should be suggested at a time when inter-party rivalry is at its peak — with Assembly elections being conducted and parliamentary elections due next year — is heartening.  

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