The Central Bureau of Narcotics (CBN), Department of Revenue, Ministry of Finance, and the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) signed a Memorandum of Understanding (MoU) to promote legitimate pharmaceutical exports while preventing the diversion of controlled substances. Dr. Dinesh Bisen, Narcotics Commissioner, represented CBN, while Raja Bhanu, Director General, represented PHARMEXCIL during the signing ceremony at the CBN Headquarters in Gwalior. The agreement aims to strengthen cooperation between regulators and the pharmaceutical industry. At the same time, it seeks to make regulatory compliance easier for exporters while maintaining strict safeguards against the misuse of controlled substances.
Strengthening India’s Pharmaceutical Export Ecosystem
India is widely recognised as the “Pharmacy of the World” and remains a major global supplier of active pharmaceutical ingredients (APIs), bulk drugs, formulations, biologics and medical devices. The pharmaceutical industry also has strong links with the chemical sector, which supplies compounds, solvents, catalysts and other critical inputs used in drug manufacturing. Consequently, this interconnected supply chain requires effective controls to prevent the diversion of certain chemicals and controlled substances for illicit purposes. The new CBN-PHARMEXCIL partnership seeks to address this challenge while supporting the legitimate growth of India’s pharmaceutical exports.
CBN’s Role in Regulating Controlled Substances
The CBN administers the regulatory, facilitation and enforcement provisions of the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985. Its responsibilities include supervising the legitimate cultivation of opium poppy, issuing authorisations for the import and export of narcotic drugs and psychotropic substances, and ensuring that essential chemical inputs do not enter illicit channels. Furthermore, the MoU supports the Government of India’s broader Ease of Doing Business agenda by introducing voluntary compliance mechanisms into the pharmaceutical export ecosystem.
PHARMEXCIL to Act as Industry Interface
- Raja Bhanu, Director General, PHARMEXCIL, highlighted the importance of trust and regulatory integrity for India’s pharmaceutical export industry. India currently supplies medicines to more than 200 countries and remains the world’s largest supplier of generic medicines. However, maintaining this global position requires strong confidence among international regulators, patients and government agencies. Bhanu noted that narcotic drugs and psychotropic substances serve legitimate pharmaceutical purposes, including anaesthesia and pain management. At the same time, he stressed the need to prevent their diversion because even limited misuse can have serious consequences.
Under the MoU, PHARMEXCIL will serve as an industry interface for CBN. It will disseminate regulatory advisories among exporter members, encourage participation in awareness and training programmes, and promote a stronger culture of voluntary compliance. Importantly, PHARMEXCIL’s role will remain facilitative rather than regulatory. The organisation will help exporters understand and follow applicable requirements while supporting communication between industry and government authorities.
Voluntary Code of Conduct for Exporters
As part of the agreement, CBN has developed a Voluntary Code of Conduct in consultation with PHARMEXCIL. The code outlines recommended practices for pharmaceutical exporters dealing with controlled substances. Since it is voluntary and non-binding, it will not interfere with normal business operations or impose additional statutory or financial obligations beyond existing laws. Member companies will nominate designated contact persons to coordinate matters related to the code and facilitate communication with the concerned authorities.
Focus on Faster and More Efficient Export Procedures
The partnership will also focus on identifying operational bottlenecks that affect compliant exporters. Subsequently, CBN and PHARMEXCIL will recommend measures to streamline export procedures and improve regulatory efficiency. The two organisations will conduct joint workshops, seminars and awareness programmes to improve industry understanding of compliance requirements. Where necessary, these initiatives will also involve government bodies such as the Central Drugs Standard Control Organisation (CDSCO) and Customs. In addition, the MoU establishes a framework for exchanging information required to achieve regulatory objectives, subject to applicable laws and confidentiality requirements.
Six-Month Action Plan for Pan-India Outreach
CBN and PHARMEXCIL have also discussed a six-month action plan to implement the partnership. The plan will focus on pan-India industry outreach, stakeholder sensitisation and the establishment of key areas for institutional and regulatory cooperation. Through these initiatives, the two organisations aim to create a more transparent and efficient compliance environment for pharmaceutical exporters.
Balancing Export Growth with Regulatory Compliance
The MoU reinforces the Government of India’s commitment to the compliant and sustainable growth of India’s pharmaceutical sector. By improving coordination between regulators and exporters, the initiative aims to reduce dwell time associated with export authorisations while continuing to protect against the misuse of narcotic drugs, psychotropic substances and controlled precursors. Therefore, the agreement seeks to achieve two complementary objectives: facilitating legitimate pharmaceutical trade and strengthening regulatory safeguards.
Third Industry Partnership for CBN
The agreement with PHARMEXCIL is the third industry-focused MoU signed by CBN. CBN previously signed an MoU with the Indian Chemical Council (ICC) in 2022, covering the basic chemical manufacturing sector. It subsequently signed another agreement with CHEMEXCIL in 2025, covering fine and speciality chemicals. As reported by bignewsnetwork.com, the latest MoU extends this collaborative approach to finished pharmaceutical exports, further strengthening coordination between the government and India’s chemical and pharmaceutical industries.
