Govt to spend Rs 3k cr to set up labs, double drug regulators
The government will spend about Rs 3,000 crore to double the number of drug regulators to 1,000 in three years and set up testing labs at ports to ensure that pharmaceutical export shipments meet global quality standards, a senior government official said in Mumbai on Wednesday.
"While following a zero tolerance policy for any laxity, the 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," Drugs Controller General (India) G N Singh told reporters.
Singh was speaking after inauguration of the three-day international exhibition of pharma and health care - iPHEX 2014 in the financial capital. He 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.
The number of regulators will increase to 1,000 from 500 at the Central level, while as many as 3,000 regulators will be deployed at the state levels, he said adding that 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," Singh said.
India's regulators including DCGI himself along with state level FDAs have all gathered here at the 'iPHEX', organised by the industry body Pharmexcil and are engaged in deliberations with regulators from 40 countries.
Joint Secretary in the Commerce Ministry Sudhanshu Pandey said the central 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, Pandey said, " The government stands behind zero tolerance when it comes to human lives. Indian laws are the toughest."
Pharmexcil Chairman 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 Pharmexcil P V Appaji said.@Source-Business Today.
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