The Rajiv Kher Task Force, which had submitted its report to the government recently, has recommended mandatory foreign site inspections to ensure quality of medicines.

"Foreign inspections to approve every site/unit/block that exports to India like any international regulatory agency should be made mandatory," the task force recommended.

To ensure quality of imported products, foreign site inspections and stringent GMP audits should be made mandatory. In addition regular audits to ensure genuineness of compliance should take place. Also parity in fees charged for drug approvals in India for foreign drugs with fees charged for approval of Indian drugs in those countries should be brought, the task force in its report said.

India imports several APIs, formulations from foreign sites. Foreign site inspection assures quality and will reduce the risk of poor quality drugs for general population. Most countries depend on rigorous inspections and rigorous data screening and evaluation to assure quality. Further, foreign inspections will create awareness and improve perception in addition to intense knowledge capture. Knowledge enhancement in public organisations flows to industry and the standards of country will enhance. Most governments charge for all costs incurred in site inspections and India may also follow suit in charging such fees for foreign products, the report said.

The task force under Rajiv Kher, joint secretary in the union commerce ministry, was constituted by Prime Minister Dr Manmohan Singh way back in July 2006 to recommend measures for increasing exports of pharmaceutical products and also to find ways and means to ease the bottlenecks coming in the way of pharmaceutical exports.

The task force's recommendation in this regard assumes significance as the union health ministry has been showing a lethargic attitude on this issue so far. Though the DCGI Dr Surinder Singh has been on record several times in the past that the government would introduce such a mechanism to ensure the quality of the products being imported from other countries, especially from China, there has been no action in this regard so far.

The Indian pharma industry has been demanding for on-site inspections of Chinese facilities and strict enforcement of registration norms for import, as the country depends on China heavily for API supply. Besides, after the Heparin controversy, many of the pharmaceutical raw materials produced by China have come under cloud across the developed world. While the Indian government is keen on introducing the quality parameters for the domestic companies by introducing the Schedule M and other such measures, it looked the other way when the industry demanded for such a check on the imported products.