Doublespeak on drug regulation must stop

Dinesh C. Sharma

Science Commentator

THE Noida police recently arrested three employees of a pharmaceutical firm on the charges of manufacturing and selling adulterated drugs in a case relating to the death of 18 children in Uzbekistan due to contamination in a cough syrup supplied by this company.

Only a few months ago, a company in Haryana was caught in a similar controversy when the Gambia reported that over 60 children had died after consuming cough syrup made by the firm. In both cases, cough syrups were found to be contaminated with a toxic chemical.

The Gambia deaths were first flagged by the World Health Organisation (WHO) and this week the US Centres for Disease Control has reconfirmed that the deaths occurred due to acute kidney injury caused by diethylene glycol (DEG) which was found in the contaminated cough syrups imported from India.

The response of Indian authorities — Union Health Ministry, Central Drugs Standard Control Organisation (CDSCO), state drug controllers and the Department of Pharmaceuticals — was lackadaisical. They all started picking holes in the statements of the WHO and the Gambia Ministry of Health. Instead of examining the WHO and Gambia findings, the central drug authority formed its committee and then blamed the WHO for not sharing information with it.

The Health Ministry put the onus on the Gambia, saying that it was the responsibility of importing countries to test products for quality before releasing them for usage. It also said the WHO had not provided “the exact one-to-one causal relation of death.”

It later emerged that the Gambia had conducted autopsies in some cases and DEG toxicity was found. To top it all, Health Minister Mansukh Mandaviya, who is also Minister for Chemicals and Fertilisers (under which the Department of Pharmaceuticals works), saw this as a conspiracy to tarnish the image of India’s pharmaceutical industry. At a meeting of heads of missions of 100 ‘partner countries’ held on February 24, Mandaviya again vouched for ‘good quality of pharmaceuticals’ being manufactured by Indian companies for mass consumption.

This public posturing reeks of doublespeak. At a supposedly closed-door meeting of Central and state drug authorities in Hyderabad on February 26, Mandaviya made a frank confession about the sorry state of drug regulation in India. He admitted, “Several fake medicines are in the domestic market. Several counterfeit medicines are also being exported, and because of this the credibility of our pharma industry is being questioned.” For this state of affairs, the minister told the officials, “The pharma industry is responsible, but before that it is our responsibility.”

As regard the regulatory system, he said, “It is not robust and there is a lack of synergy between state and Central regulation.” The present drug regulatory system, according to the minister, is fragmented between state regulatory bodies, Central drug regulators and the Department of Pharmaceuticals. Mandaviya’s speech was streamed live on his official YouTube channel for close to eight minutes before the live telecast was stopped midway and the feed was removed subsequently.

The Health Ministry may have taken down the video from the public domain, but the cat is out of the bag now. Mandaviya’s statement confirms what has been argued by experts and civil society bodies for long — the presence of substandard, fake and spurious drugs in the Indian market due to lax drug regulation. It also confirms that such drugs are being sent to other countries and are responsible for adverse events, as reflected in the recent Gambia and Uzbekistan cases as well as many others in the past.

The minister’s statement shows that he agrees with the stand of whistleblowers and health activists about the weak regulatory system and its fragmented nature; and that there is a need to set the house in order. If the minister knows that the drug regulation is so bad, then why is he or the government not acting? Instead, why does he defend the regulatory system and the pharma industry in public whenever adverse reports like the Gambia and Uzbekistan emerge? Now that we know what he thinks of the system, he should stop speaking with a forked tongue because the bad quality of drugs is directly related to the lives of people.

The rot in the regulatory system is not new. In 2012, a parliamentary committee investigated the functioning of the CDSCO and exposed the dark side of drug regulation at the Central and state levels. Not much has changed since then as most of the recommendations have remained on paper despite follow-up committees and so on. Successive governments too have not shown the political will needed to reform the system. On the other hand, regulation is increasingly being seen as a hindrance to the growth of the pharma industry and ease of doing business.

Prime Minister Narendra Modi has said the market size of the pharma sector is around Rs 4 lakh crore, and there is scope for this to go up to Rs 10 lakh crore. This should surely be the target, but it should not be done by compromising safety, efficacy and standards of drugs — both for domestic and foreign markets.

If the goal of the government is to make affordable and efficacious drugs available for all, a holistic approach is needed. Today, the market is flooded with multiple brands for one molecule, available at different price points and varying efficacy. There are several irrational combination drugs. As there are multiple brands, companies use unethical marketing practices to lure doctors.

Just a few thousand Jan Aushadhi Kendras can hardly make a difference unless they are backed by proper supply chains. The original idea of these centres — Ram Vilas Paswan, as Minister for Chemicals and Fertilisers, pioneered it in 2005 as part of the UPA’s common minimum programme — was that the supplies of generic drugs would come from Central and state public sector units. Most of them are now sick or have been closed. So, action is needed on multiple fronts, beginning with a resolve to make the regulatory system effective and responsible.

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