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New Delhi: The Central Drugs Standard Control Organization (CDSCO)—beset by controversies related to spurious drugs and lawsuits and allegations of civil rights abuses related to unethical clinical trials—is set for a an overhaul. G.N. Singh, who heads CDSCO as the drugs controller general of India, spoke in his first ever interview about the ongoing debates over the clinical trials and pharmaceutical industry. CDSCO is in the process of introducing new rules for the approval of drugs, clinical trials and fixed dose combinations. Edited excerpts:

Do you think India’s image as a global supplier of low-cost, generic drugs has suffered due to the extent to which spurious drugs are available in the local market?

Singh: India supplies affordable drugs to 218 countries. Indian medicines are known for their quality and affordability. The figures quoted in the media range from 10-25% of drugs in the country being spurious. These are completely unsubstantiated reports. The World Health Organization (WHO) had last year vouched for the quality of Indian drugs. Multinational pharmaceutical companies are trying to tarnish India’s image in the international market. There are people with mala fide intentions who have been spreading such information.

The controversy over the Indian clinical trial industry refuses to die down. How much of it, in your opinion, is a lapse in governance?

Singh: The matter is currently sub judice, so I will refrain from commenting on the matter in the Supreme Court. There is a lot of confusion regarding clinical trials at various levels. This is mainly because there were no rules, only guidelines, until recently, which has created a lot of misinformation.

The civil society organizations had been claiming thousands of deaths annually are caused by unethical clinical trials. We have analysed the data and ‘adverse drug events’ and deaths directly attributable to clinical trials range between 15-21 per year. The clinical trial industry is no killing machine as it has been represented in the past few years. The high-level committee (Ranjit Roy Chaudhury committee) will soon be setting guidelines for approval of new drugs, clinical trials, banning of drugs and fixed dose combinations (FDCs) in the process of streamlining this sector.

Do you think the new compensation guidelines for clinical trial victims balance the interests of industry and patients?

Singh: Multinational pharmaceutical companies earn so much money from (them) but are very reluctant when told to compensate patients. Companies don’t do justice to victims of clinical trial injuries. We are trying to make the rules stricter and enforcement tougher. Any patient getting injured during the trial—due to the trial—will now get compensation as well as free medical aid. Another aspect we are working on is to have severe punishment for those who flout the norms. We are responsible for the patient. Earlier, only the industry and the regulator were dominating the debates in this subject. We have placed, or are trying to place, the patient at the centre of these developments.

How will the drug approval process change once the Ranjit Roy Chaudhury committee submits its recommendations?

Singh: There are 11 New Drug Approval Committees (NDACs) at CDSCO looking at the regulatory aspect of the approval process. Earlier, we used to internally, within CDSCO, decide whether to approve a new drug or not. Now, subject experts across the country will approve a drug. Besides, safety, efficacy and quality requirements are more clear now. We aim to have a system-based approach. The process of approval will take a little longer in the new regime but it is a small price to pay for public safety.

CDSCO has been plagued by understaffing and not having enough qualified employees. Is this issue being addressed?

Singh: Within this week, the CDSCO is expecting to add 350 additional posts, recruitment for which will be done through the Union Public Service Commission (UPSC). In 2008, CDSCO had only 12 drug inspectors and 32 positions were vacant. Right now, we have 65 inspectors with 90 positions in the process of being filled through UPSC. In three months, all positions will be filled. Over the next two years, we will have the skilled manpower to regulate effectively.

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