India to double drug regulators ; set up testing labs at ports say top Govt officials at ‘iPHEX’

India to double drug regulators ; set up testing labs at ports say top Govt officials at ‘iPHEX’

 Mumbai, May 21, 2014

The Indian government will more than double the number of regulators  in three years  and set up state-of- the art testing labs at ports to ensure the pharmaceuticals and drugs  exports shipments  meet global quality standards while following a zero tolerance policy for any laxity, senior officials from the Health and Commerce Ministries said at the international exhibition for pharma and healthcare ‘ iPHEX’  said  here today.

The strong message was sent at the three-day event beginning today with buyers from 125 countries thronging the exposition. 

Addressing a press conference   Dr G N Singh, Drugs Controller General (India) after inauguration of the ‘ iPHEX’ , Dr Singh said the Central Government will be sending over Rs 3,000 crore in the next three years (under the 12th Plan) towards enhancing the capacity of the regulators both at the Centre and state levels. While the number of regulators will increase to 1,000 from 500 at the Central level, as many as 3,000 regulators will be deployed at the state levels.  In India, the regulatory system works at the dual level – at the Central and state levels.

“ India’s reference system ( for drugs testing and IP) will be at par with the top world standards in two-three years and will even match the  US in three-five years,” Dr Singh said . India’s  regulators including DCGI himself along with state level FDAs have all gathered here at the ‘ iPHEX’ , organized by the industry body Pharmaexcil and are engaged in deliberations with regulators from 40 countries.

Joint Secretary in the Commerce Ministry, Mr Sudhanshu Pandey, told the media that the Union Government is following a “ zero tolerance” policy for ensuring that India not only maintains but further strengthens its ranking in the world pharmaceuticals market.  He said these measures on quality assurance are even more important when a big opportunity would be unfolding in the off-patent generics in the next few years.

“ More than 160 drugs will go off-patent till 2018 …” he said. When asked about some concerns , Mr Pandey made it clear. “ Government stands behind zero tolerance when it comes to human lives. Indian laws are the toughest,” he said.

Chairman of the Pharmaexcil Mr Ashutosh Gupta said the industry and the government are working in tandem to increase the spend on the Research and Development . The industry has also been in touch with the government seeking special package for the small and medium enterprises under the Technology Upgradation Fund.

Over 500 global companies from 125 countries are participating in the three-day exposition showcasing India’s manufacturing strength.  

“ The Indian pharmaceutical industry is preparing for the next level of scaling up with the help of regulators and will be on top of the quality,” Director General of the Pharmaexcil  Dr P V Appaji said.

Chairman of the iPHEX Organising Committee Mr Bhavin Mehta said the ‘iPHEX’ has become a much sought after  event among the global  buyers who are looking up to India as a dependable source of affordable drugs.


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