India Issues Pharmaceutical Manufacturing Clarification

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Jun. 5 – The Ministry of Commerce and Industry in India has issued a clarification to combat negative media allegations regarding the quality of manufactured pharmaceuticals for export and reports of counterfeit drug operations (hereinafter referred to as the ‘Clarification’). The Indian government does not directly deny such allegations, and instead touts the pharmaceutical industry’s export numbers and strong presence in the United States and European Union. The release also introduces the track and trace measures, planned to launch in 2014, which will bolster India’s regulatory channels.

The Clarification affirms the rigor of India’s regulations providing for the manufacturing and export of pharmaceutical products, and it’s “requirement for continuous monitoring of quality related aspects including complaints of sub-standard/falsified drugs from various countries.”

Despite media reports to the contrary, the Indian government asserts its safe and expedient pharmaceutical capabilities. The Clarification seeks to bolster India’s reputation as eager to comply with international regulations and to compete in the global drug market.

The Clarification noted that the Drugs Controller General of India (DCGI) is responsible for approving licenses for specific categories of drugs, such as blood products, IV fluids and vaccines. The DCGI regularly meets with State authorities and pharmaceutical regulators to ensure that India adheres to international manufacturing practices.

The Indian government flaunts the capabilities of their drug manufacturers, insisting that instances of US Food and Drug Administration (FDA) penalization constitutes an anomaly. Of the 550 drug manufacturing sites in India registered with the FDA, 323 have been approved as of March 31, 2013. Furthermore, as of April 30, 2013, over 350 sites have been EU-endorsed for good manufacturing practice.

To increase regulation and oversight, the government has taken recent action to develop a track and trace measure. If launched, there would be an online filing and tracking system to allow for greater ease of use and transparency, and to allow for better monitoring of the supply chain.

Overall, India occupies a prime position in the pharmaceuticals industry due to low costs and high quality manufacturing.

The Clarification speculates that allegations of “spurious drugs” sourced from India are only “desperate attempts by other countries” intimidated by India’s pharmaceutical clout. Though these claims are otherwise unstated in the Clarification, trends do support India’s notion of export power in the pharmaceutical industry. India is 4th largest in the world in terms of production volume and 13th in export value of bulk actives and dosage forms.

The Clarification further highlights the export growth of Indian pharmaceuticals:

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