The drugs don’t work: Indian reporters need to ask regulators tough questions on substandard medicines

With every passing day, there is a new scandal uncovered by foreign regulators who inspect manufacturing plants in India that supply drugs for their patients. The government’s reaction in most cases has been to either deny the existence of any manufacturing deficiencies or to order an investigation whose conclusions are rarely publicised in the press.

While the Indian press has done a good job of reporting the outcome of regulatory inspections conducted by western regulators, they rarely ask Indian regulators and bureaucrats tough or sometimes even basic questions on whether these manufacturing facilities comply with Indian law when it comes to quality of medicines that are sold in India.

Sample this report in The Times of India on the government ordering a second investigation into alleged wrongdoing at GVK Biosciences. The report discusses how the first investigation by Central Drugs Standard Control Organization, the national regulator, found no data fraud and that the Union Ministry of Commerce was now constituting a second committee to conduct an investigation into GVK Biosciences.

The two most obvious questions that pop into a reader’s mind are: first, why is the government constituting a second committee if the first committee absolved the company of any wrongdoing; and, second, what was the reason given by the first committee for giving GVK Biosciences a clean-chit? The newspaper report, however, doesn’t answer either of these questions. The devil often lies in the detail and unfortunately, sometimes, the Indian press prefers to ignore the devil.

Another glaring example of unsatisfactory reporting pertains to the increasing instances of Indian drug manufacturers being hauled up by western regulators for violation of basic good manufacturing practices (GMPs) in their plants. Most of these plants also supply the Indian market and, therefore, affect Indian patients as well. In such circumstances shouldn’t reporters be asking questions whether Indian regulators have ordered recalls of the drugs manufactured in these very manufacturing plants that are consumed by the Indian patient?

More importantly, shouldn’t the Indian press be asking why Indian drug inspectors didn’t discover these violations of GMPs as all Indian manufacturing facilities are required to be inspected by state regulatory authorities.

The most common narrative, driven primarily by the industry and parroted by the regulator, is that the standards by which western regulators assess compliance is different from the one India follows.

This is hogwash.

Nowhere in Indian law does it condone repeated testing into compliance until one gets the “right” result.

If GMPs are being violated and data is being fabricated at Indian manufacturing facilities and nobody is being held accountable even after foreign regulators provide objective evidence to back their allegations, then clearly the Indian regulators are failing their jobs.

If a superintendent of police (SP) fails to maintain law and order in a district, the media is likely to publicly hold the SP accountable by name. This is a necessary exercise in a democracy to fix accountability. Why don’t we then see the same standard being applied when it comes to drug regulation? Every state has several drug inspectors, headed by a chief drug controller. If these bureaucrats are not executing their jobs as intended, it is the duty of the Indian press to call them out. Yet, we rarely see this happen.

Similarly, when the Indian press discusses policy issues regarding drug regulation, it simply doesn’t ask difficult questions. Take for example this recent report in the Mint where the Drug Controller General of India (DCGI) GN Singh claims that India will amend its laws to “bridge the gap between Indian manufacturing practices and the WHO good manufacturing practices (GMPs)”. The DCGI concludes: “The new standards in India will be up to the global marks.” The DCGI’s statement is followed by a brief discussion on the possible business impact of such increased regulation. What the report omits to mention is the fact that GMP standards prescribed by the World Health Organization (WHO) have already been incorporated into Schedule M of the Drugs and Cosmetics Act as far back as 2001.

The press release put out by the government in 2001 while announcing the amendments to Schedule M, clearly states so. In pertinent part, it says: “The present amendment to “Schedule M” is a progressive mechanism to harmonize the production of drugs and pharmaceuticals and to meet the requirements of international guidelines as recommended by WHO.” Therefore, if Indian manufacturers supposedly follow WHO-prescribed GMP standards in Schedule M, what then is the DCGI talking about? We wouldn’t know because nobody asked him this question.

I have been wanting to ask this question, but the DCGI rarely turns up at public events – like the World Congress on Public Health in Kolkata held earlier this year. I was a member of a panel for which he was invited. It, therefore, becomes more important for journalists with access to ask these pertinent questions.

What is perhaps even more intriguing is the DCGI’s second statement in the same news report where Singh says: “Out of around 8,000 manufacturers in India, only a few are following the WHO guidelines.” If Schedule M is already the equivalent to WHO-GMP standards and Schedule M is the law of the land, doesn’t it follow that all Indian manufacturing units are required to follow WHO-GMP standards? More importantly, if these manufacturing facilities are not complying with the prescribed standard, what has the DCGI done about it? This is the question the DCGI should have been asked.

India is facing a national crisis when it comes to the substandard quality of its drugs. If we are serious about holding the pharmaceutical industry accountable for its actions, we desperately need the Indian media to step up its game and improve the standard of its reporting.

It is understandable that reporters who cover business topics for the industry may not want to jeopardise their sources when it comes to reporting on quality, safety and ethical breaches by the industry. After all, access is the name of the game. But there is a larger, national interest at stake here. By segregating these roles, it is possible to reduce the conflict of interest.