India to double drug regulators; to set up testing labs at ports: Govt officials

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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 in the Union health and commerce ministries said.

Speaking on the sidelines of the three-day international exhibition for pharma and healthcare ‘iPHEX’, which began here on May 21,  Drugs Controller General of India (DCGI) Dr G N Singh said the central government will be spending 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.

Joint secretary in the commerce ministry, Sudhanshu Pandey, said 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 as more than 160 drugs will go off-patent till 2018.  He also made it clear that the government stands behind zero tolerance when it comes to human lives.

India’s regulators including DCGI himself along with state level FDAs have all gathered in Mumbai at the ‘ iPHEX’, organised by the industry body Pharmaceuticals Export Promotion Council of India (Pharmaexcil) and are engaged in deliberations with regulators from 40 countries.

Chairman of the iPHEX organising committee 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.

  Source: PharmaBiz


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