The Rajiv Kher Task Force, which had recently submitted its much awaited recommendations to the government on measures to be taken to improve the pharma exports, has asked the government to negotiate with foreign countries for automatic approvals for Indian facilities recognised by countries with mutual recognition and agreements.
For products manufactured in USA and Australia there is a mutual acceptance. However, the same US FDA approved product in India will still need a plant inspection by Australian authorities. As Australia accepts US facility without any inspection, the same should be extended to US approved facility in India in an auto mode. We may negotiate for such mutual agreements, the report said.
The Task Force further asked the government to take up a bilateral discussion to accept Indian facilities approved by US or EU or TGA or HPB Canada or MCA South Africa without further inspections by various countries in the ROW. For example, even Nigeria, Ghana, etc want to inspect our facilities although our facilities are already approved by US or EU, etc. There is a justification to inspect if such facilities are not approved by any eminent countries.
The, Rajiv Kher Task Force was constituted by prime minister Dr Manmohan Singh way back in July 2006 to find ways and means to ease the bottlenecks coming in the way of pharmaceutical exporters in the country. Its key recommendations included comprehensive measures for accelerating the growth of generic pharmaceutical industry in the country, enhancing India's R&D, promoting contract manufacturing, drug discovery & clinical trials, Indian System of Medicines & Ayush.
The task force, headed by Rajiv Kher, joint secretary in the union ministry of commerce, had held several rounds of meetings with all the stakeholders including the pharma industry and the officials before finalising its findings. The task force exclusively on pharma exports was constituted in the wake of the pharma industry making strides in the country during the last some years. There has been an increasing activity in the pharma export front as it has grown by leaps and bounds, especially during the last some years. Today the pharma sector alone contributes about five per cent of the total exports of the country.