Thakur is considering plans to set up a patient advocacy group that will aim to increase transparency and accountability among drug makers in India.DIVYA RAJAGOPAL | ET Bureau | 15 February 2016, 12:30 PM IST
He’s considering plans to set up a patient advocacy group that will aim to increase transparency and accountability among drug makers in India, according to people aware of the matter. Thakur is said to have approached public relations companies in India to initiate the campaign that will try to raise matters related to drug safety standards.
Thakur, however, denied any such plans in an email to ET. However, others said Thakur has shared his ideas with a few people on how the process could be taken forward.
Such a move, if it does come about, would take place at a time when top Indian drug makers face US Food and Drug Administration strictures over non-compliance with the quality standards.
Since November 2015, the US FDA has issued warning letters to leading Indian drugmakers Sun, Dr Reddy’s and Cadila for not complying with good manufacturing practices. Though warning letters are not uncommon in the drug business, observations on data integrity and quality of manufacturing are serious matters, experts said.
Also, since the Ranbaxy scandal, there has been increased scrutiny of drug makers in India by the US FDA. Nearly 40% of drugs consumed by US patients is manufactured by Indian generic makers. The companies are in firefighting mode as 40% of revenue at large Indian generic makers comes from the US market.
If Thakur was to indeed launch such an initiative, the Indian drug controller may be nudged into establishing similar standards of quality as practiced by global regulators, experts said. In 2012, a parliamentary committee report on health and family welfare revealed mismanagement at the Central Drug Control Board and alluded to collusion with pharmaceutical companies.
“The committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO (Central Drugs Standard Control Organisation),” the committee had noted. “For decades together it has been according primacy to the propagation and facilita tion of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured.”
Experts have repeatedly called into question inspection norms follo wed by Indian agencies for enforcement of quality standards at local sites. Although the Drug Controller General of India puts up a periodic list of the companies that are found supplying drugs that are not of standard quality in the country, experts feel the system needs to be tightened further to scale up to global standards.