The Central Bureau of Narcotics and the Pharmaceuticals Export Promotion Council of India have signed a Memorandum of Understanding to facilitate legitimate pharmaceutical exports and prevent product diversion. The agreement aims to balance export promotion with regulatory oversight for APIs, bulk drugs, formulations, biologics, and medical devices.

The Central Bureau of Narcotics (CBN) and the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) have signed a Memorandum of Understanding (MoU) to facilitate legitimate pharmaceutical exports, streamline operational procedures, and prevent the diversion of pharmaceutical products.

The agreement was signed on Monday between the CBN, which operates under the Ministry of Finance, and PHARMEXCIL, an organization set up by the Ministry of Commerce and Industry. The primary objective of the partnership is to support international trade while ensuring strict regulatory oversight.

According to a statement issued by the finance ministry, the initiative recognizes India's established role as a leading global supplier of active pharmaceutical ingredients (APIs), bulk drugs, formulations, biologics, and medical devices. The framework is designed to balance the promotion of these exports with effective monitoring mechanisms.

The CBN functions as the administrative agency responsible for enforcing the provisions of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. Its responsibilities under the act include supervising the licit cultivation of opium poppy, issuing authorisations for the import and export of narcotic drugs and psychotropic substances, and monitoring essential chemical inputs to prevent illicit diversion.

As part of the new agreement, the government will work in consultation with PHARMEXCIL to develop a voluntary code of conduct that establishes recommended operational practices for the pharmaceutical industry.

Additionally, the partnership will focus on identifying existing operational bottlenecks and recommending measures to simplify and streamline legitimate export procedures specifically for compliant pharmaceutical exporters.

To support implementation, the pharmaceutical industry will endeavor to nominate designated 'Contact Persons' from member companies to coordinate matters associated with the newly established voluntary code of conduct.

"This Memorandum of Understanding between the Central Bureau of Narcotics and PHARMEXCIL marks a significant step in balancing export growth with regulatory compliance for India's pharmaceutical sector. By streamlining legitimate trade procedures while reinforcing controls against product diversion, this framework provides much-needed clarity for exporters dealing in APIs, bulk drugs, and medical devices. Implementing a voluntary code of conduct will further encourage industry accountability and help maintain India's reputation as a reliable global supplier." — Dr. Shishir Gupta, Founder & CEO, StartupLanes

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