The Indian government has recently implemented several key regulatory updates impacting the pharmaceutical and medical device industries. These changes span marketing practices, incentives for pharmaceutical manufacturing, clinical trial regulations, and food safety standards.
Curbing Unethical Marketing Practices in Medical Devices
On September 6, 2024, the Department of Pharmaceuticals (DoP) issued the Uniform Code for Marketing Practices in Medical Devices 2024 (UCMPMD) to address unethical marketing practices by medical device companies. This code mandates that all product claims align with registration documents and that comparisons between devices must be factual and not disparaging. Promotional materials must include essential information like manufacturer details and usage precautions. The UCMPMD also restricts the use of healthcare professionals' (HCPs) names and photos in promotional content.
Medical representatives (MRs) are prohibited from using inducements to gain interviews with HCPs, and companies are accountable for their MRs' compliance with the UCMPMD. The code also sets guidelines for evaluation samples and demonstration products, ensuring samples are only provided to HCPs and demonstration products are not used on patients. Continuing medical education events in foreign locations are generally prohibited, except for advanced clinical training with specific DoP approval. Gifts or pecuniary benefits to HCPs or their families are banned, as are travel and hospitality facilities unless the person is a speaker or participant at a training event approved by DoP.
Complaints regarding breaches of the UCMPMD can be lodged with designated Ethics Committees, with strict timelines for submission and resolution. Penalties for violations include suspension from associations, public reprimands, corrective statements, and recovery of improperly given money or items. In cases involving governmental agencies, the committee may forward recommendations through the DoP.
Amendments to Scheme on Strengthening Pharmaceuticals Industry
The DoP has modified the guidelines for the scheme on Strengthening of Pharmaceuticals Industry, specifically the sub-scheme on Revamped Pharmaceutical Technology Upgradation Assistance Scheme. Incentives for pharmaceutical units have been increased to INR 2,00,00,000 (Indian Rupees two crore), up from INR 1,00,00,000 (Indian Rupees one crore), while maintaining the same average turnover criteria. Expenditure on production equipment is now considered for subsidy calculation. The requirement for a detailed gap analysis for online applications has been replaced with a simpler version. The subsidy disbursement schedule has also been revised, with the first installment now at INR 1,00,00,000 (Indian Rupees one crore) and the second at INR 2,00,00,000 (Indian Rupees two crore).
New Rules for Clinical Research Organizations
The Ministry of Health and Family Welfare (MoHFW) has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024, effective April 1, 2025, which include provisions for the registration of Clinical Research Organizations (CROs). A CRO is defined as an entity, commercial or academic, to which a sponsor delegates tasks related to clinical trials or bioavailability/bioequivalence studies. CROs must register with the Central Licensing Authority (CLA) before conducting such studies involving new or investigational drugs on human subjects. Registration is valid for five years, subject to suspension or cancellation. Centers already registered for bioavailability/bioequivalence studies under the NDCT Rules are automatically considered registered as CROs.
Other Key Updates
The Food Safety and Standards Authority of India (FSSAI) has extended the provision for instant issuance of licenses/registrations nationwide, excluding a few states/union territories. Testing fees for PAN-India surveillance programs on food products have been reduced by 50%. Amendments to the Food Safety and Standards Rules, 2011, empower adjudicating officers to hold inquiries for offenses under specific sections of the Food Safety and Standards Act, 2006.
