📷 Image: Wikimedia Commons / MoE of India
Health
Government proposes mandatory batch‑release authorisation for drug manufacturers
✍️ TripuraTimes.com
🗓 04 Nov 2026, 10:03 AM
👁 10
The central government has announced a draft policy requiring all pharmaceutical firms to obtain batch‑release authorisation before marketing medicines.
New Delhi – The Union Health Ministry has tabled a draft regulation that would make batch‑release authorisation compulsory for every drug manufacturer before any batch can be released into the market. The proposal aims to tighten quality control, ensuring that each production lot meets prescribed safety and efficacy standards.
Under the draft, manufacturers must submit detailed batch records to a designated authority, which will verify compliance with Good Manufacturing Practices (GMP) and conduct random testing. Only after receiving formal clearance can the batch be distributed to pharmacies and hospitals.
The ministry says the move is intended to curb sub‑standard medicines and protect public health, especially in the wake of recent recalls of contaminated batches. Industry bodies have been invited to comment on the draft before it is finalised.
If adopted, the regulation will apply nationwide, affecting both domestic producers and multinational firms operating in India. The government has indicated that a phased implementation timeline will be announced to allow companies to adapt their quality‑assurance processes.
Stakeholders are expected to submit feedback within the next 60 days, after which the final rule will be published in the Gazette of India.
Under the draft, manufacturers must submit detailed batch records to a designated authority, which will verify compliance with Good Manufacturing Practices (GMP) and conduct random testing. Only after receiving formal clearance can the batch be distributed to pharmacies and hospitals.
The ministry says the move is intended to curb sub‑standard medicines and protect public health, especially in the wake of recent recalls of contaminated batches. Industry bodies have been invited to comment on the draft before it is finalised.
If adopted, the regulation will apply nationwide, affecting both domestic producers and multinational firms operating in India. The government has indicated that a phased implementation timeline will be announced to allow companies to adapt their quality‑assurance processes.
Stakeholders are expected to submit feedback within the next 60 days, after which the final rule will be published in the Gazette of India.