Healing a weak regulator

Weaknesses in India's drug regulatory regime and the constraints and questionable decisions of the drug regulator could mar the country's reputation in global markets

By now, it is abundantly clear that the world will need to live with coronavirus for some more time despite several vaccines being available. The virus mutations will require more and better vaccines to be developed.

Last year, it had briefly looked as if different players and countries had put aside their individual interests to find a solution for the pandemic jointly. There was unprecedented cooperation between multinational drug firms, research labs, biotech start-ups and governments, to develop cures for the virus. By the end of 2020 though, vaccine nationalism, vaccine politics and profiteering had reared their heads.

Developed countries stockpiled vaccine doses far in excess of their requirements. Western countries with production capacities refused to help even their allies. And vaccine developers are not willing to give up patent rights. India finds itself standing tall amidst all this. As the biggest producer of vaccines in the world, and tie-ups with international vaccine makers in place, plus a number of domestic firms working to develop indigenous vaccines, its problem is the inoculation drive rather than shortage of vaccines. It has taken moral leadership by offering vaccines free not only to neighbours but others as well. It is also leading the effort to persuade big pharma to give up their Covid vaccine patents for the greater good.

This should have been the perfect opportunity for the Indian drug industry to move up the value chain of original vaccine development. While India produces two-thirds of the world’s vaccines by volume, in value terms its share is negligible — 5-6 per cent. India has so far focused on producing and developing vaccines like MMR, Polio, Hepatitis B, Influenza, Diptheria, etc, which are inexpensive and low margin. It is a space that the big drug makers of the world have vacated.

Covid, however, could have genuinely put India’s vaccine makers into a higher global orbit. But weaknesses in India’s drug regulatory regime and the constraints and questionable decisions of the drug regulator could well trip it up and mar the country’s reputation in global markets.

The Central Drugs Standard Control Organisation (CDSCO) and its boss, the Drugs Controller General of India (DCGI), fall under the Union Ministry of Health and Family Welfare. Loosely patterned on the Foods and Drugs Administration (FDA), on paper it complies with all the global standards, including those of WHO, USFDA and the European Union. However, despite recent improvements and additional resources provided by the government, the CDSCO and DGCI still suffer from inadequate resources, lack a strong focus on quality and rigorous data, and the ability to enforce compliance.

The Indian regulator has courted controversies even in the past — for allowing irrational fixed dose combinations, bad record-keeping and approving drugs for uses they had not been cleared for in other countries. But it has been its approval of drugs and vaccines for Covid that has attracted enormous adverse publicity.

Though the DGCI approves drugs based on the recommendations of the Subject Expert Committee (SEC) of the CDSCO, the data on which these recommendations and approvals are based is often shrouded in mystery. In the middle of 2020, its emergency use approvals to Itolizumab, a drug developed by Biocon originally to treat psoriasis, and Favipiravir, a drug marketed by Glenmark, attracted a fair amount of criticism from doctors and others for being given approval without adequate, large-scale studies demonstrating efficacy.

However, the biggest controversy has been the case of the vaccine approvals. While critics have questioned the small sample size of the bridging study done by Serum Institute of India for Covishield, which is based on the Oxford/AstraZeneca vaccine, the big controversy has surrounded the approval of Bharat Biotech’s Covaxin, which was cleared despite not having completed Phase III trials to prove efficacy. (The data of Phase III trials of Covaxin are expected in mid-March). Moreover, the DCGI has been quick to dismiss all complaints of adverse effects of any vaccines.

While most regulators around the world have taken some short cuts in approving vaccines for emergency use, none have done it on the basis of so little data, say experts. Or with so little visible monitoring of adverse effects during the clinical trials and inoculation drive.

In the past couple of years, the Union government has sanctioned additional funds to the CDSCO to strengthen the drug regulatory system across the country (including centre and states). Several laws have also been passed or modified to improve the standards of regulatory framework in the country and give more teeth to the CDSCO.

Despite this, as the decisions taken by the regulator in the past two years show, its focus on asking for more rigorous data from companies approaching for approvals, enforcing better designed large scale clinical trials and bridging studies of drugs developed elsewhere on the Indian population is still far behind its global peers.

Indian vaccine makers are used to meeting the stringent approval processes of the FDA and other regulators when they sell abroad. There is no reason why they should be allowed to submit anything less for approvals in India. Both the regulator and the government need to understand this. The Indian pharmaceutical industry has the potential to rise up the global vaccine value chain — but controversies about domestic approvals on the basis of sketchy data will do it no favours. 

The writer is former editor of Business Today and Businessworld and founder and editor of Prosaicview, an editorial consultancy