In a significant step towards facilitating legitimate international trade and preventing the diversion of pharma products, the Central Bureau of Narcotics (CBN), Department of Revenue, Ministry of Finance, Government of India and the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL), set up by Ministry of Commerce and Industry, Govt of India signed a Memorandum of Understanding (MoU) today at the CBN Headquarters in Gwalior.

Recognizing India’s position as a leading global supplier of active pharmaceutical ingredients (APIs), bulk drugs, formulations, biologics, and medical devices, the MoU aims to balance the promotion of India’s pharmaceutical exports with effective regulatory oversight.

Role of CBN under the NDPS Act, 1985 Functioning under the Department of Revenue, Ministry of Finance, the Central Bureau of Narcotics (CBN) is the agency administering the facilitation, regulations and enforcement provisions of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. Under the NDPS Act, the CBN holds the critical mandate of supervising the licit cultivation of opium poppy, issuing authorizations for the import and export of narcotic drugs and psychotropic substances, and ensuring that essential chemical inputs are not diverted for illicit use.

This collaborative framework with PHARMEXCIL is a strategic extension of the Government of India’s National Roadmap of Ease of Doing Business. The Memorandum of Understanding (MoU) executed today broadens this comprehensive approach by integrating, voluntary compliance mechanisms directly into the pharmaceutical export ecosystem to secure international supply chains.

Signing Ceremony and Dignitaries The formal signing ceremony saw the exchange of MoU documents between Dr. Dinesh Bisen, Narcotics Commissioner, representing the CBN, and Shri Raja Bhanu, Director General of PHARMEXCIL.

Key Highlights of the MoU:

• Voluntary Code of Conduct (VCC): The Government, in close consultation with PHARMEXCIL, will develop a Voluntary Code of Conduct setting out recommended practices for the industry. This code will remain voluntary and non-binding, ensuring it does not interfere with normal business operations or create additional statutory or financial burdens on exporters beyond applicable laws.

• Trade Facilitation & Ease of Doing Business: The partnership will focus on identifying operational bottlenecks and recommending measures to streamline legitimate export procedures for compliant pharmaceutical exporters.

• Capacity Building: Both parties will organize joint workshops, seminars, and awareness campaigns for exporters, in coordination with relevant government institutions like CDSCO and Customs wherever required.

• Information Sharing: The MoU establishes a framework for the exchange of necessary information to achieve regulatory objectives, subject to applicable laws and confidentiality obligations. Furthermore, the pharma industry will endeavor to nominate ‘Contact Persons’ from member companies to coordinate matters associated with the VCC.

Following the signing, the dignitaries engaged in detailed deliberations on the way forward, focusing on a six-month action plan. This plan will prioritize pan-India outreach, stakeholder sensitization in collaboration with PHARMEXCIL, and establishing core areas of institutional and regulatory cooperation.

This MoU reaffirms the Government of India's commitment to ensuring the compliant and sustainable growth of the pharmaceutical sector, nurturing growth and boost of export sector, by reduction of dwell time for export authorizationswhile safeguarding against the misuse of narcotic drugs, psychotropic substances, and controlled precursors.

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SR/KMN

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