It’s not a subject that Narain Sarviya ever thought he’d pursue. But he has travelled 900-odd kilometres from Indore to Delhi to stand outside the Supreme Court. The issue being discussed inside the hallowed portals is clinical drug trials, conducted to evaluate the effectiveness and safety of medicines. The labourer has missed three days of daily wages to know what’s happening. “I lost my mother in a trial five years ago. I want justice,” he says.

And justice, perhaps, is round the corner. On Monday, the apex court slammed the Centre and states for the way clinical trials are conducted in the country. The court sought details from the Centre on the number of trials that took place between 2005 and 2012, deaths and side effects caused by the trials and the compensation paid.

Sarviya’s mother suffered a paralytic attack in 2005 and was taken to an Indore hospital. She was sent back home with a box of medicines, given free of cost. “The doctor monitored her progress regularly. But her condition deteriorated and she became mentally unstable. She died in 2007,” says Sarviya. Two years ago, when her name appeared on a list prepared by the Economic Offences Wing investigating drug trials in Madhya Pradesh, he learnt that his mother was a victim of a trial testing of a drug.

Sarviya is part of a group called the Clinical Trial Victims Association in Indore. “It is a registered society, perhaps the first of its kind in the world, to fight for the rights of people affected by drug trials,” says founder Dr Anand Rai, who is also the man behind the public interest litigation filed in the Supreme Court in February on unethical clinical drug trials.

Voices are being raised nationwide, from Madhya Pradesh to Andhra Pradesh, against unethical drug trials, against drug companies not paying compensation for the adverse effects of clinical trials, and against regulatory authorities not taking action against errant doctors and pharmaceutical companies, forcing the authorities to sit up and take notice. Last month, the Drug Technical Advisory Board, constituted by the health ministry in 2011, recommended amendments to the Drugs and Cosmetic Rules.

The new stipulation states that drug investigators will have to video record trial subjects giving their informed consent to a study. As of now, a written consent is all that is required. But trial subjects often don’t understand what they are signing. Video recording will ensure that investigators explain things properly to subjects. In June 2009, the government decreed that trials have to be registered under the Clinical Trials Registry – India.

Though clinical drug trials in India constitute only 2 per cent of global trials, India became an attractive destination in 2005 after an amendment was made to the Drugs and Cosmetics Act. Now the second and third phase of trials by foreign pharmaceutical companies can be conducted in India at the same time as in other parts of the world. Earlier, a drug trial could take place in India only after it was successfully tested in another country.

Drug companies have been casting a favourable eye at India for several reasons. The country has a huge population with a varied genetic pool, a wide range of diseases ranging from malaria to diabetes, as well as skilled staff. Low costs are another allure. “Conducting a trial in India is about 40 per cent cheaper than in the US, Europe and Asian countries such as South Korea and Japan,” says Dr Shubhangi Desai, head, clinical operations, Asia and North America, Siro Clinpharm, a Mumbai-based Contract Research Organisation (CRO) which monitors drug trials. But the costs in India are comparable to those in countries such as the Philippines, Malaysia, Thailand and China, she adds.

According to clinicaltrial.gov, a global registry on trials, 1,33,939 trials are currently on in 180 countries. North America heads the list with 67,254 trials. The total number of trials registered in India is 2,059. The Boston Consulting Group (BCG), the management consultancy firm, says the clinical trial industry in India is worth $498 million — substantially less than the $1 billion it hoped to reach by 2011.

With more and more companies eyeing India, and the ensuing dissent, the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority that evaluates the safety, efficacy and quality of drugs, came up in August with draft guidelines to calculate the compensation to be paid by pharmaceutical companies to victims of clinical trials. At present, no fixed mode of calculation exists.

The health ministry also woke up last year and came out with draft rules containing guidelines for registering CROs and ethics committees. It notified a draft format for informed consent, and another to authorise the drug regulator to allow state authorities to take administrative actions in case of irregularities.

“But the basic question we need to ask is: why are we conducting trials of new drugs which Indians won’t be able to afford? Everything else is secondary,” argues Dr C.M. Gulhati, editor of the medical journal Monthly Index of Medical Specialties. “Moreover, these are only recommendations. How soon shall they be implemented is yet to be seen.”

Those in favour of trials stress that the huge market opens up vistas of employment for clinical research professionals. India has some 150 CROs, of which the top 20 contributed to over 70 per cent of the total industry revenues, says a spokesperson of the Indian Society for Clinical Research, a Mumbai-based association of clinical research professionals, quoting a recent report by Frost & Sullivan, the consultancy. “They have estimated a compounded annual growth rate of 15.48 per cent,” the spokesperson adds.

“But what should have been a boon for the nation in terms of generating employment and enhancing research has become a means to exploit poor and illiterate people,” Dr Rai says.

Former Pfizer India director Dilip G. Shah, who’s now secretary general of the Indian Pharmaceutical Alliance, arrives at the nub of the problem when he points out that the opening up of the market in a lax environment has led to a situation where regulators cannot keep pace with the growth of the industry. “The large and serious players ensure compliance with their internal standards. However, some new players without prior experience do not,” says Shah.

Participants, for instance, are enrolled without knowledge of what is being tested. Some are lured with money. “Many youngsters and women have made participation in clinical trials their main source of income. They earn up to Rs 10,000 for a 10-day study,” says Purushottam Parmar, an activist with Raah, an Ahmedabad-based non-government organisation seeking to spread awareness about clinical trials.

An offer of money or other inducements violates the rules. According to the Indian Council of Medical Research’s guidelines, participants may be paid only for the inconvenience and time spent, and should be reimbursed for expenses incurred in connection with their participation in research.

Worse, drug companies often refuse to acknowledge the casualties that occur during drug trials. In May, a parliamentary panel report pulled up the CDSCO, condemning the “collusive nexus” among drug manufacturers, some CDSCO functionaries and medical experts. It questioned the mechanism in which speedy drug trials were approved and the credibility of experts on the ethics committee. CDSCO did not comment despite repeated calls and email.

On the flipside, the rumpus and tighter regulations have affected growth in the industry. According to BCG figures, the number of new trials in India climbed from 115 in 2005 to 260 in 2008; growth subsequently has been flat. In 2011, the figure actually tumbled to 169. The Ahmedabad-based Association of Contract Research Organizations (Acro) maintains that business opportunities worth Rs 200-300 crore have been lost because of delays in the regulatory process in the past one year. “This has forced some local CROs to open centres in the other Asian countries and has pushed sponsors to consider other locations,” says an Acro spokesperson. Thailand and Malaysia are emerging as the favourite destinations.

Those who have benefited from drug trials — these, after all, are the predecessors to medicines — feel that the ultimate end is worth the glitches. “I can vouch for the benefits of clinical drug trials. My mother-in-law, who was suffering from breast cancer, was part of a trial at the Tata Memorial Centre in Mumbai and benefited from the process,” says Pune-resident Manika Goyal.

Clearly, a trial is a double-edged weapon. Goyal’s mother-in-law has benefited from it. And Sarviya certainly has not.

Clinical course

After pre-clinical trials on animals, a drug is tested for safety and efficacy in human beings. After getting approval from the Drugs Controller General of India (DCGI), the drug company allows a trial to be conducted. The trial facilitators approach a doctor (investigator) who then submits the proposal to an ethics committee, either from the institution where the trial is held or an independent body, which further gives its stamp. It is then registered as a drug being tested in India. The trial is conducted by the investigator and the report is submitted to the DCGI.

big business

Global clinical trial market: $45 billion

Indian market: $498 million

Total trials registered in India: 2,059

(Figures as per ISCR, BCG study)

bitter pill

Clinical trial deaths in India

2007: 132

2008: 288

2009: 637

2010: 668

2011: 438

2012 (till June 30): 211

(Figures provided by RTI activists and Monthly Index of Medical Specialities)