The Delhi Medical Association (DMA) has expressed interest in cooperating with the central government's plans for post marketing surveillance of drugs in India. The association felt that for any adverse drug reaction monitoring mechanism to succeed, the government has to cooperate with the general practitioners of the country.
Speaking to Pharmabiz.com, Dr Anil Bansal, President Elect, DMA related the non-functioning of the existing ADR centers to the absence of proper networking with doctors. "If the government is seriously interested in feedbacks, they should cooperate with us. There has to be proper awareness among the doctors on the existence of ADR centers. The association is willing to take up this job of creating awareness if the government can come forward with appropriate plans to ensure active participation of the doctors", he said.
Dr Bansal said that the general practitioners are coming across many cases of adverse drug reactions in their hospitals. "But we don't know where to inform. As of now there is no prescribed format by which we should record all these observations. There is no authority to analyze such a data and suggest some measures. Let the government come out with such plans and we would be willing to help at the association level", he said. The current practice of restricting ADR centers to research institutes or medical institutions will not be effective until there is a regular flow of ADR related information from the general practitioners, he said. He also wanted the government to recognize the doctors who can come out with correct observations on the drug reactions.
Reacting to the comments, sources with the Office of the Drugs Control General of India said that too much of vigilance can be counterproductive also. "People could be confused. Patient may be suffering from some other problems also. Only experts should be allowed keep track of ADRs" they said.
Dr Bansal, on the other hand said that the involvement of doctors can be limited to the collection of first hand data, which otherwise would be much less. "The doctors can submit the reports to the experts or refer the patients to the ADR centers", he said.
The office of the DCGI however has its own doubts. "We cannot accept suggestions from too many persons. It will create a situation where vested interests can play a role," they said.
ADR monitoring, known as Phase IV trials is the post marketing surveillance (PMS) of new drugs in the West. DCGI sources said that the "Indian situation is totally different from the West. Here we don't really have new molecules or drugs. Though we are terming "new drugs", the ones that are manufactured or marketed in the country for the first time are not "new drugs or new molecules" in the real sense. All those drugs have already passed ADR monitoring in other countries. What we need is an ADR system based on Indian realities, they said.
The government is in the process of launching a pharmaco-vigilance programme in this regard soon. About 30 medical colleges in the country would be given assistance to set up necessary infrastructure for developing pharmaco vigilance centers. The DCGI sources felt that these centers can effectively take up the ADR monitoring of new drugs and also look into the negative side effects of drugs, which are being reviewed for its negative effects world over.