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CDSCO officials attend biopharmaceutical industry lobbying group meeting: Objections raised


CDSCO officials attend biopharmaceutical industry lobbying group meeting: Objections raised

New Delhi: Expressing concern over the participation of senior officials of the national regulatory body Central Drugs Standard Control Organization (CDSCO) in a meeting in the US by an American biopharmaceutical industry lobbying group, various civil society groups have raised objections.

In this regard, the groups have written to health minister JP Nadda stating that the timing of the health ministry through CDSCO ’s participation was fraught especially in light of the recent Special 301 report of the US Trade Representative where for the 27th year in a row India was placed on the priority watch list for its alleged poor enforcement of intellectual property regulations.

“Many of the demands from the biopharmaceutical industry are reflected in the 2019 Special 301 Report, which spreads blantant lies and wrong propaganda against India, with a motive to undermine the image of India’s generic industry,” stated the letter.

The Special 301 Report is prepared annually by the Office of the United States Trade Representative (USTR) that identifies trade barriers to United States companies and products due to the intellectual property laws, such as copyright, patents and trademarks, in other countries.

India has continued to reject the report calling it unilateral and has insisted that India’s IP laws are fully compliant with WTO regulations.

Recently, the 13th Annual BioPharma & Healthcare Summit scheduled has been organised by the USA-India Chamber of Commerce (USAIC), which is dominated by pharmaceutical transnational corporations.

The letter to the minister also pointed out that many of these companies were also members of the US pharmaceutical industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA) whose “lobbies often attack India’s intellectual property regime and drug regulations”.

“The USAIC Summit’s agenda is dominated by transnational companies and their interests. These kinds of conferences are often used for lobbying and advancing industry interests. The participation of policy-makers and regulators in such meetings sends a wrong signal and increases the Indian government’s vulnerability to undue corporate influence from pharmaceutical transnational corporations on India’s policy-making and regulations,” stated the letter.

PhRMA’s submission to the USTR “contained several illegitimate complaints and accusations against India” and sought regulatory changes through the backdoor route to block the entry of generics, pointed out the letter.

It also referred to statements made by US Commerce Secretary Ross on May 7 about market access barriers faced by US companies which also cited Indian price controls on medical devices and pharmaceuticals as ‘obstacles’ for US companies.

Referring to media reports that the government might relax price regulation of medical devices and dilute the price cap on coronary stents and knee implants in response to US pressure, the civil society groups urged the government to not succumb to US pressure. They also urged the minister to take measures to prevent the undue influence of US industry associations like PhRMA and USAIC on India’s policy-making.

Also Read: CDSCO denies approval for Akums Acid reflux FDC in Capsule form



Source: with inputs
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