The sharp setback that the once- promising clinical trials sector in India has suffered (see “Clinical trials gone haywire”, Business Standard, August 1) can be attributed to poor medical ethics, business growth outstripping skills supply, increasing civil society vigilance, and the appalling state of regulation.
Doctors at government and private hospitals in Indore made lakhs through clinical trials during 2005-10, when the senior-most professor at the Mahatma Gandhi Medical College had a take-home pay of Rs 75,000, said a report in The Times of India. Even though all patients were recruited through the medical college – which was the trial site – and its facilities were used for trials, the college got nothing.
“In the case of 15 clinical trials, instead of obtaining permission from the on-site ethics committee of the medical college, permission has been obtained from strange non-verifiable entities claiming to be ethics committees located thousands of kilometres away in Pune or Ahmedabad,” the Monthly Index of Medical Specialities’ editor, C M Gulati, was quoted as saying.
A leading doctor who is a co-discoverer of a polio vaccine tried a vaccine on a two-day-old when it was meant for one-month-olds, Headlines Today reported. The parent was told it was part of a free government vaccination programme, not a clinical trial. The father came to know of this only when he started to get his son treated by a skin specialist for white spots, a side effect.
A heart-attack patient was made to sign a one-page consent form that spoke of a study, not a clinical trial. The original 16-page consent form mentioned the side effects, risks and insurance terms. After participating in the trial for cardiac problems, he developed dementia. The actual insurance papers indicated that mentally ill patients were only insured against physical injuries during trials. So volunteers were not eligible for compensation if they developed mental problems while participating in clinical trials.
Members of Swasthya Adhikar Manch, a network of NGOs that have filed Right to Information (RTI) applications to learn how clinical trials were being conducted, had demanded that the accused doctors be transferred to ensure a free and fair probe. Otherwise, they could easily influence poor volunteers for trials and manipulate documents. The Madhya Pradesh government eventually fined five doctors Rs 5,000 each for conducting clinical trials on mentally ill patients and passed the matter on to the Centre. Union Health Minister Ghulam Nabi Azad, on the other hand, told Parliament that the 78 doctors who conducted clinical trials were under the administrative control of the Madhya Pradesh government.
In its report on the Central Drugs Standard Control Organisation (CDSCO), the parliamentary standing committee on health and family welfare has highlighted the lack of numbers and of skills. All you need to be the drug controller general of India is a BPharm with experience in manufacturing, testing or enforcement of drug regulation. A reputed scientist in drug discovery and development may not qualify. The United State Food and Drug Administration (USFDA) head, on the other hand, is an experienced doctor, scientist and public health specialist.
Two reports in The Financial Express have highlighted the state of affairs at the CDSCO. India has not had a permanent drug controller since 1999, barring a three-and-a-half-year stint ending last year. During 1999-2008, two successive drug controllers held additional charge of this key post. The current situation is a reflection of historical ad hocism and neglect. The USFDA has a budget of $2.5 billion and a staff of 11,500; the Indian regulator under $5 million and a little over 100. “Lack of technical competence, improper confidential data management, misplacing of files and absence of a delegation system when an officer in charge goes on leave are delaying the approvals inordinately,” another report in the same paper quotes Mita Nandy, senior vice-president, LG Life Sciences, as saying.
An industry veteran says that while empowering the CDSCO and putting in qualified people, it is necessary to give it autonomy and the right to defend itself publicly. “We need a transparent and predictable system. Why can’t investigation reports of the CDSCO be put on the website? The USFDA publishes assessment reports for new products; we don’t. There is no inspection to check if good clinical practices are being followed.” Another industry expert adds, “Applications are not cleared for months. We want the government to show a pathway for the next five years. Unfortunately, the CDSCO is being used to fight corporate rivalries.”
How low things had sunk can be gauged from the fact that both the experts have affirmed to this writer that posts at the CDSCO have come to command a market-discovered price, like some posts in the police and excise departments. Things have to get better as they can’t get worse.