New Delhi: India has not reported a single instance of medicinal side effects from drugs for the last three years to an international drug monitoring database set up by the World Health Organization (WHO).
Some industry observers see this as evidence of India’s lax monitoring of so-called adverse drug reactions, or ADRs, in patients, or pharmacovigilance.
Such adverse reactions are believed to be the fourth largest cause of mortality and morbidity globally.
Medical malady: A chemist shop in south Delhi. Experts say a “bottom up” approach is needed where chemists and doctors are responsive and alert to any adverse reactions being brought to their notice by patients. Photograph: Rajeev Dabral / Mint.
Drugs typically throw up newer side effects than were known during clinical trials once they begin to be administered across large groups of patients. Collecting this data is crucial for patient safety as well as fine-tuning medical research.
The database of Sweden-based Uppsala Monitoring Centre, which carries out WHO’s international drug monitoring programme, shows no ADRs were reported from India between 2005 and 2007, a near impossibility, say experts, given India’s population, and the massive number of medicines and combinations being introduced into the market.
“The system (of pharmacovigilance) has failed in India. There is lack of training, medical assessors in drug controller’s office, insufficient funds and no motivation at all,” says Pipasha Biswas, managing director of Symogen Ltd, an outsourcing services company with operations in the UK and India that focuses on pharmacovigilance-related se-rvices.
Prafull D. Sheth, vice-president of the international think tank of pharmacists, the International Pharmaceutical Federation, agrees that there was a need to separate the “good drugs and the bad drugs”, a largely neglected area in India.
“No data has been generated and if it has been generated, it has not been analysed,” he says. “What is happening to the huge network of centres that have been set up?”
Sheth was referring to the elaborate structure that has been set up in India with 24 peripheral pharmacovigilance centres that are supposed to feed information into five regional centres that, in turn, funnel information to two zonal centres.
At the head of the pyramid is the office of Drug Controller General of India (DCGI) that is supposed to collate the countrywide data before sending it off to the database maintained by Uppsala Monitoring Centre.
Drug controller Surinder Singh acknowledges it has been a problem and is assuring a multi-pronged solution had been found.
“By end of this year, we intend roping in all the medical colleges and creating a drug monitoring cell within their (attached) hospitals. This will give us a good network to begin with for collecting data,” maintains Singh.
Explaining the problems with existing pharmacovigilance centres, he says that the centres and training of personnel were being funded out of a World Bank capacity building project that came to an end in June, effectively freezing finances.
The initiative will now be funded by the government and “clearances are in the pipeline”, Singh says.
The drug regulator claims that adverse reactions data was “being collected but not sent to Uppsala because of some fee demanded by them” but says that issue, too, has been resolved now.
As for 2005 and 2006, Singh, who took over as controller earlier this year, has no explanation as to why data was not forwarded to Uppsala.
According to Uppsala’s website (www.who-umc.org), between July 2006 and June 2007, 68 member countries out of 83 pooled adverse reaction case reports into the international database of the WHO programme, taking the total number of stored cases to 3.87 million.
“The total number of processed and accepted ADR cases was 201,462 and the greatest number of these came from the US (100,659), Germany (19,830), the Netherlands (16,552), Thailand (9,602) and Australia (7,801),” notes a report on the centre’s website.
The numbers from India, which joined the initiative in 1998, were coming in during the initial years, albeit in small numbers. The centre found a large number of the reports thorough in terms of details filled in, procedures followed and linking the drug to a particular physiological event. But, gradually, reports from India starting being incomplete and eventually stopped.
Sheth says that the system collapsed because it “has been top-down”, laden with a bureaucratic structure while it should have been “bottom up” where the chemists, pharmacists and even doctors are responsive and alert to any adverse reactions being brought to their notice since patients will first mention it to them.
“The whole world is discovering (the reports), then why aren’t we despite being the fourth largest drug market by volume?” asks Sheth.
India’s laws require drug makers to conduct post-marketing surveillance studies of the medicines they manufacture or import, provisions that are blatantly overlooked by companies, say some industry experts.
“Not all companies do it,” admits Singh.
India’s Schedule M of the Drugs and Cosmetics Act, 1940, while elaborating on “good manufacturing practices”, says: “Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority.”
Schedule Y of the same Act, which deals with the protocols of clinical trials, also stipulates: “On approval of a new drug, the importer or the manufacturer shall conduct post-marketing surveillance study of that new drug...during the initial period of two years of marketing.”
But, experts say, the system encourages companies to cover up adverse reactions rather than report all of them to the regulator.
For instance, UK’s drug regulator officials “are very thorough in looking for (adverse reaction) reports while inspecting a company,” noted Biswas. “Not only are the regulators strict, the consumers are very aware and liability suits can be prohibitively costly for companies.”