Central Bureau of Narcotics and PHARMEXCIL sign MoU to regulate controlled substances in pharma exports

The Central Bureau of Narcotics (CBN), Department of Revenue, Ministry of Finance, and the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL), set up by the Ministry of Commerce and Industry, have signed a Memorandum of Understanding (MoU) to promote legitimate pharmaceutical exports while preventing the diversion of controlled substances.

The documents were exchanged between Dr Dinesh Bisen, Narcotics Commissioner, representing CBN, and Raja Bhanu, Director General, PHARMEXCIL at the CBN Headquarters, Gwalior.

Under the MoU, the CBN has developed a Voluntary Code of Conduct in close consultation with PHARMEXCIL, setting out recommended practices for the industry. The code remains voluntary and non-binding and is designed not to interfere with normal business operations or create statutory or financial burdens on exporters beyond applicable laws. Member companies will nominate contact persons to coordinate matters associated with the code.

The two sides will also identify operational bottlenecks and recommend measures to streamline export procedures for compliant exporters. Joint workshops, seminars and awareness campaigns will be organised, in coordination with government institutions including the Central Drugs Standard Control Organisation and Customs where required. The MoU further establishes a framework for the exchange of information needed to meet regulatory objectives, subject to applicable laws and confidentiality obligations.

Both sides also deliberated on a six-month action plan that will prioritise pan-India outreach, stakeholder sensitisation and establishing core areas of institutional and regulatory cooperation.

Speaking on the occasion, K. Raja Bhanu, Director General, PHARMEXCIL, said: "Narcotic drugs and psychotropic substances are essential raw materials for our industry, used in anaesthesia and pain management, but we are equally conscious that diversion, even in small measure, can cause serious harm. Through this MoU, PHARMEXCIL commits to act as a genuine industry interface for CBN disseminating regulatory advisories to our exporter members, mobilising their participation in awareness and training programmes, and building a culture of self-regulation that does not wait for enforcement to arrive at the factory gate."