The drug regulator has proposed mandatory patient monitoring cells in pharmaceutical companies due to reduction in time gap between drugs launches in developed markets and India. The idea is to quickly address adverse effects of new launches. The proposed monitoring cells would also keep a watch on withdrawal of drugs in developed countries and suggest similar moves for the domestic market. “A strong pharmaco-vigilance system is required to ensure the continuous monitoring and evaluation of the new safety data generated under the real-world conditions on the effects, side-effects, contraindications, drug interactions, new indications and use in new populations of all drugs,” a proposal from the drug regulator’s office, reviewed by Business Standard, said. The proposal has been submitted to the Ministry of Health and Family Welfare for consideration. Though many leading drug makers monitor post marketing data for their key products, at present there are no provisions under the law for companies to mandatorily have any such cell and record data for adverse effects of a product after its launch. According to the proposal, the cells may be headed by “qualified medical personnel capable of monitoring the safety of the marketed products”.
The note also points out that for assessing risk-benefit profile of a medicine, the Indian regulatory system was so far primarily dependent on the moves in the regulated and developed markets such as the US, Europe and Japan, where drugs were launched much before they were in India. However, in recent years, while many domestic companies have started investing in R&D to develop new drugs on their own, the time lag in launch of a drug in India as compared to developed markets has reduced considerably. “As a result, for such drugs the long-term safety data is not available at the time of their marketing in India,” the proposal said. The regulator has also raised concerns regarding reportage of adverse effects in the country. There were instances in the past when drugs were banned and withdrawn in other countries due to safety issues, but continued to be marketed in India because of lack of adequate data. Regulatory experts view the proposed move as an immediate necessity towards better regulation. However, some also emphasise on the need for the regulator itself to monitor such data as companies alone cannot be trusted with the same.