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 international trade in pharmaceutical products while strengthening measures to prevent their diversion for illicit use.
The MoU was signed at the CBN headquarters in Gwalior, between Narcotics Commissioner Dr. Dinesh Bisen and PHARMEXCIL Director General Raja Bhanu.
The partnership aims to balance the promotion of India’s pharmaceutical exports with effective regulatory oversight, particularly given the country’s position as a major global supplier of active pharmaceutical ingredients (APIs), bulk drugs, formulations, biologics and medical devices.
The CBN, under the Department of Revenue, Ministry of Finance, is responsible for administering regulatory and enforcement provisions under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. Its mandate includes supervising the licit cultivation of opium poppy, authorizing the import and export of narcotic drugs and psychotropic substances, and preventing the diversion of essential chemical inputs for illicit purposes.
Key areas of the MoU include:
Voluntary Code of Conduct (VCC): The government, in consultation with PHARMEXCIL, will develop a voluntary and non-binding Code of Conduct setting out recommended practices for pharmaceutical exporters. The code will not impose additional statutory or financial burdens on exporters beyond applicable laws.
Trade Facilitation and Ease of Doing Business: Both parties will work together to identify operational bottlenecks and recommend measures to streamline legitimate export procedures for compliant pharmaceutical exporters.
Capacity Building: Joint workshops, seminars and awareness campaigns will be conducted for exporters, in coordination with relevant government institutions like CDSCO and Customs, where required.
Information Sharing: The MoU establishes a framework for sharing necessary information to achieve regulatory objectives, subject to applicable laws and confidentiality obligations. PHARMEXCIL member companies will also be encouraged to nominate contact persons to coordinate matters related to the Voluntary Code of Conduct.
Following the signing, officials discussed a six-month action plan that will prioritize pan-India outreach, stakeholder sensitization, and the establishment of core areas of institutional and regulatory cooperation.
The government noted that the initiative is aimed at supporting the compliant and sustainable growth of India’s pharmaceutical exports by reducing delays in export authorizations while strengthening safeguards against the misuse of narcotic drugs, psychotropic substances and controlled precursors.
