It’s time drug regulation system is reviewed

Dinesh C. Sharma

Science commentator

Amidst the public glare on the Agnipath scheme and the political crisis in Maharashtra appeared a report of alleged corruption involving India’s much-celebrated pharmaceutical sector and the country’s drug regulatory system. This case of bribery is different from such cases reported routinely and those involving much higher sums of money because it has implications for people’s health. The Central Bureau of Investigation (CBI) has arrested a top official of the Central Drugs Standard Control Organisation (CDSCO) — the regulatory body for drug approvals in India — and a senior official in charge of regulatory affairs of a Bengaluru-based pharmaceutical firm as well as officials of a company acting as middlemen on behalf of the pharma company.

According to the report, the company officials bribed a joint drug controller to speed up clearance for one of its flagship products — the injectable insulin. Those involved in bribing the official were caught red-handed and arrested and 11 locations were raided in Bengaluru, Delhi and Gurugram.

The process of marketing new drugs — those developed in India and elsewhere — in the Indian markets is quite elaborate, involving multiple steps and players. Starting with pre-clinical studies to establish the safety and efficacy in animals to clinical trials in humans to ensure safety, efficacy and dosing, a new drug has to undergo extensive testing. Data from each stage has to be presented to the drug regulator before the start of the next phase. If all goes well, marketing approval is given. In the case of drugs already approved by the regulators in mature markets such as America and Europe, the Indian rules allow bypassing some stages of approval, provided the results of all clinical data gathered elsewhere are presented and the regulator is satisfied with it.

In the case of emergencies like a pandemic, the drug regulator may permit the simultaneous conduct of different clinical trial phases. Assisting the regulator in the technical approval process is a mechanism called the Subject Expert Committee (SEC), consisting of external experts. Given the high stakes involved in drug development and competitive pressures, drug companies always seek to speed up the regulatory process. They hire middlemen and companies that handle paperwork relating to the approval process, just as they outsource clinical trials to third parties.

In the present case, the drug had undergone clinical trials in other markets and the company was seeking a waiver of phase III clinical trials in India. If all its data was in order, it would have gotten the approval in any case. The CBI has alleged that the company bribed the CDSCO official to get a favourable response from the SEC for its application. The officer attended the SEC meeting held on May 22, 2022, and tampered with its proceedings by replacing the word ‘data’ with ‘protocol’. This has serious regulatory implications. The company or persons acting on its behalf tried to influence a critical regulatory procedure in connivance with an insider. It also exposes malfunctioning in the CDSCO division which handles the SEC. The conduit company, which counts several large pharma companies among its clients, also needs to be investigated thoroughly.

Above all, the probity of the SEC members becomes suspect. While the company, Biocon, has denied any wrongdoing, the CDSCO and Health Ministry have kept mum. As a follow-up, the CBI should investigate not only all the cases handled by the compromised CDSCO officials but also the approvals given by this particular SEC as well as other SECs. A parliamentary panel in 2013, which investigated the functioning of the regulatory system, had found that the SEC set-up was a sham. Many approvals were given for the waiver of clinical trials in India, and some files were not even traceable.

The panel which reviewed the approvals given by the SECs found that ‘an overwhelming majority are recommendations based on personal perception without giving any hard scientific evidence or data. Such opinions are of extremely limited value and merely a formality’. Still worse, the panel found documentary evidence to conclude that many opinions were written by ‘the invisible hands of drug manufacturers and experts merely obliged by putting their signatures’. The language used in the opini on given by different experts was identical, confirming the suspicion that they were all written by the manufacturers concerned. The parliamentarians suspected that drug companies even suggested the names of the so-called experts to the CDSCO so that they could have a pliant SEC.

Moreover, the decision to seek expert opinion was with the non-medical functionaries of the CDSCO, which left ‘the doors wide open to the risk of irrational and incorrect decisions’, with the potential to harm public health. Experts connected with the regulatory process must be made to declare ‘conflict of interest’ outlining all past and present pecuniary relationships with drug companies that stand to benefit from their recommendations. Even such basic precautions were not taken.

Based on the evidence that emerged from examining the files of the CDSCO and testimonies of experts, the panel was unequivocal in concluding that “there is sufficient evidence on record to conclude that there is a collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts.”

Has the situation changed since 2013? No, as shown in the latest case involving the SEC that waived the clinical trials for the insulin shot developed outside India. Experts have questioned the approvals granted to some Covid drugs by the SECs during the pandemic.

It has been almost a decade since the last investigation into the functioning of the drug regulatory authority in India took place. The government and Health Ministry owe an explanation if any corrective steps have been taken since then to reform the regulatory system and make the process of drug approvals evidence-based and transparent.

The present case provides an opportunity for another exercise to clean it up. The review should not only cover the CDSCO but also the functioning of the Food Safety and Standards Authority of India (FSSAI). In the name of ‘ease of doing business’, it is unethical for the government to let the regulators sleep with the regulated, and in the process, compromise people’s health and food safety. 

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