Govt to spend Rs.1,750 crore to boost drug regulatory system, exports
In an effort to boost the manufacturing and export of pharmaceutical products, the government will spend Rs 1,750 crore to tighten the drug regulatory system over the next three years. A proposal for strengthening and up-gradation of regulatory system at both at Centre and state levels was approved by the Cabinet Committee on Economic Affairs on Wednesday. “Out of the total amount of Rs.1750 crore, an amount of Rs.900 crore will be spent on strengthening central structures and Rs.850 crore will be made available to the state governments, after signing a Memorandum of Understanding,” an official statement said. The funds are meant for adding equipment and manpower in the existing drug testing laboratories and setting up of new laboratories for testing drugs, medical devices and cosmetics. The scheme is also aimed at providing mobile drug testing laboratories, creation of additional manpower for regulatory structures, including for new and emerging areas such as stem cell, regenerative medicine, biologicals and medical devices in addition to drugs. “The measure will help enhance quality, safety and efficacy of drugs and other medical products manufactured in the country, and thereby help mitigate the disease burden as also increase export of pharmaceutical products from India,” the statement said, adding that the move will also help trigger growth of the domestic medical devices sector. India is one of the largest manufacturers of drugs and exports pharmaceutical products to over 200 countries. India’s pharmaceutical product export was more than $15 billion last year. The move came days after European Union imposed a blanket ban on the sale of more than 700 Indian generic drugs in European countries. The ban also prompted the Indian government to suspend its negotiations on free trade agreement with the 28-nation bloc. Apart from EU, several countries have expressed concern over compliance of the international norms by Indian manufacturers. In the last six months, US food and drug regulator has denied the import of more than 1,000 Indian products in the past six months. At least 1,150 refusals of Indian products were recorded in the last six months, Commerce Minister Nirmala Sitharaman told parliament on Wednesday, citing data from the USFDA (United States Food and Drug Administration). The products which were refused entry included patent medicines and generic medicines apart from other items such as fried snack foods, bakery, spices, basmati rice, food with supplemental nutrients, soft drinks, herbals and botanicals. “The reasons given for the refusals vary from problems in packaging, labelling, misbranding, alleged contamination, and residue levels etc,” the minister said.
August 13, 2015 | 2:58pm IST.
to success.