In a major relief to the exporters from Karnataka, the CDSCO recently issued an order delegating powers to grant no objection certificates (NoCs) to the deputy drug controller (DDC), sub zone, Shanthy Sunashekaran. This notification will now enable the DDC to issue NoCs for the manufacturers of unapproved or approved new drugs and banned drugs in the state of Karnataka for exports.
Prior to this notification, exporters had no other options than to travel all the way to Chennai for obtaining NoCs for manufacturing these drugs for exports. This proactive initiative from the CDSCO office comes as a part of aggressive follow-up by the commerce ministry and the Pharmaceuticals Export Promotion Council of India (Pharmexcil), which have been consistently raising the issues faced by the Karnataka based exporters with the higher authorities.
Following a major push by them, one of the key issues affecting the exporters from Karnataka has been sorted out that will further enhance and encourage positive export related activities from the state. Dr P V Appaji, director general of Pharmexcil informed that time and again the exporters from the state have been raising their concerns over the cumbersome process involved in traveling to Chennai for the same which have been both costly and a time consuming affair for them.
“We had taken up this issue with DCGI based on requests received from exporters from Karnataka on their ongoing problems and challenges to go all the way to Chennai for obtaining NoCs. It comes as a great news for us that the DCGI has favourably considered our request on priority basis and issued this order, which is sure to go a long way in helping the exporters from Karnataka to contribute in the growth of pharma exports of our country.”
It is understood that Karnataka has seven US FDA, eight MHRA and 82 WHO certified plants in addition to several international approvals including UNICEF, MCC South Africa, ANVISA, PIC/S, which reinstates Karnataka pharma’s capability as a hub for quality outsourcing. Karnataka pharma reported revenues to the tune of Rs.13,500 crore clocking a 9 per cent growth rate in the year 2014-15. Of this, Rs.5,800 crore constituted exports earnings which grew at 7 per cent of the total national exports. The state pharma units account for 1.2 per cent of the total national industry numbers.