Teena Thacker

Indias drug regulator has clarified that new drugs not approved anywhere globally must undergo the full domestic regulatory process, even if Indian patients participated in global clinical trials. CDSCO said such applications require comprehensive safety and efficacy evaluation under existing rules.

Regulator flags unauthorised mfg & sale of male infertility drug

During the first quarter of fiscal 2027, India's pharmaceutical exports soared to $8.10 billion, showcasing remarkable strength in drug formulations and biologicals, which together made up roughly three-quarters of the total. Both bulk drugs and vaccines saw substantial double-digit growth. North America and Europe served as vital markets for Indian medicines, indicating a promising future for the nation's pharmaceutical sector.

The government has initiated 950 enforcement actions against pharmaceutical companies since December 2022. These actions aim to improve the quality of locally made medicines and prevent spurious drug sales. More than 1,100 cough syrup manufacturers are facing intense audits due to quality concerns. Drug manufacturing premises are inspected periodically to verify compliance with good manufacturing practices. Risk-based inspections are now prioritized based on a company's risk profile.

Drug Quality Regulations: More than 1,100 cough syrup manufacturers are undergoing intensive audits, while drug manufacturing units are being subjected to periodic and risk-based inspections to strengthen quality controls and curb spurious medicines.

Amid growing demand for domestic production, prominent drug manufacturers are investing billions in the U.S. market, focusing on manufacturing and research expansion.

The rising use of GLP-1 weight-loss drugs such as Ozempic and Mounjaro is creating a new consumer market in India, with companies developing protein- and fibre-rich foods, nutrition supplements and beauty products aimed at addressing side effects of rapid weight loss.

India's drug regulator has cleared the path for local lenacapavir manufacturing. Two Indian pharmaceutical companies received waivers for local clinical trials. This move will improve access to the HIV prevention injection. Lenacapavir is a breakthrough twice-yearly injection for HIV prevention. Patient groups had urged the regulator to expedite this process.

Medical device makers now avoid loan licenses for outsourced sterilization services. This change simplifies business while industry leaders express concerns about new labeling rules. Printing sterilizer license numbers on device labels may hinder export flexibility and cause shipment delays. Manufacturers worry about losing the ability to choose the fastest available sterilization facility. The government also recognized the European Union for clinical investigation waivers.

H1N1 cases have increased significantly, and monsoon fevers are at seasonal highs. Companies are issuing safety guidelines and advising employees to avoid crowded places. The Union Ministry of Health is closely monitoring the situation across India. Health experts state there is no cause for panic or alarm. Seasonal influenza is generally mild for healthy individuals, but at-risk groups need timely medical advice.