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Severe shortage of well equipped drug inspectors hurting pharma exports: ASSOCHAM

New Delhi, Dec 9 : India has a meager number of 1,500 well equipped inspectors for more than 10,000 factories engaged in pharmaceutical products leading to the country’s products facing regulatory hurdles in the overseas markets like the US which follow stringent protocols for the manufacturing processes, staes a study by ASSOCHAM and RNCOS.

“While at times, the US Food and Drug Administration (FDA) gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices,” said Secretary General, D S Rawat, ASSOCHAM.

“However much we may wish otherwise, the pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health,” Rawat said.

The mismatch between the domestic regulatory mechanism and the international regime is resulting in recall and rejection of drugs made by even some of the well known companies, leading to unrest and frustration. In the long run, the pharmaceutical exports during the fiscal year 2013-14 reported USD 14.8 billion of drug exports would take a setback.

According to the study, India ranks fourth in pharmaceutical production in the world with a production output of about USD 31 Billion in 2014. The country has a 1.4 percent share by value and 10 percent by volume in the global pharma industry. India is one of the leaders in pharmaceutical exports.

The pharmaceutical manufacturing is managed by multiple regulatory authorities, which include the Central Regulatory Agency, the office of the DCGI (Drugs Controller General of India) under Central Drugs Standard Control Organization (CDSCO) with zonal offices and the State FDAs. This makes the process of obtaining license, for pharmaceutical product manufacturing complex.

The pharmaceutical industry in India has a concurrent regulatory practice, which is sometimes poorly manned and poorly headed by less knowledgeable pharmacists who are not properly trained. Lower awareness among such personnel regarding the quality norms leads to non-uniform implementation of regulatory standards.

With the absence of global harmonization of quality systems makes it all the more challenging for India that exports to US, Europe, Australia, Japan, etc, to comply with a plethora of regulatory guidelines across the globe, said Rawat. (ANI)