Centre's plan to make batch certification mandatory for drug manufacturing companies

The Union Health Ministry has taken strict measures to monitor the quality of medicines. The Ministry has proposed that all pharmaceutical companies will have to officially appoint a qualified expert to authorise the sale of every batch of medicines in the market. This information was provided by the government on Tuesday. Under the draft amendments to the Drugs Rules, 1945, every drug manufacturing company will have to appoint an expert specifically responsible for batch release. Additionally, companies will have to provide a batch release certificate in a prescribed format and maintain proper records for every lot produced.

According to the Health Ministry, currently, drug manufacturing companies are required to declare technical personnel who oversee production and testing, but there is no specific provision for identifying the person who authorises batches for sale. Mint was the first to report that the government plans to tighten the rules in February 2025 regarding this scheme. According to the Health Ministry, batch release is an extremely critical stage in the pharmaceutical manufacturing process, which involves a comprehensive review of relevant quality standards and documentation before the distribution of any batch.

The Health Ministry added that these proposed amendments will help in strengthening the compliance of Good Manufacturing Practices applicable to manufacturers. At the same time, the regulatory framework governing drug quality assurance will also be made more robust. According to a ministry statement, the main objective of these proposed amendments is to increase accountability in the drug manufacturing process by introducing clear regulatory requirements for the authorisation of personnel responsible for batch release.

Under the revised framework, applicants seeking manufacturing licences under the relevant provisions will have to appoint a properly qualified and experienced person for batch release. Along with this, batch release records must also be maintained as per the prescribed requirements. The aim of these proposed requirements is to establish clear accountability for this task, ensure traceability of batch release decisions, and provide an additional layer of oversight on product quality.

Amid concerns regarding the quality of medicines manufactured in the country, this development becomes very significant for India's $60 billion pharmaceutical industry. Instances have emerged where alleged toxic substances were found in cough syrups manufactured in India and sent abroad. In 2022 and 2023, child deaths occurred in Gambia and Uzbekistan that were linked to these cough syrups. Additionally, last year, at least 24 children died in Madhya Pradesh and Rajasthan due to contaminated medicines. Following these incidents, the drug regulator has intensified risk-based inspections of local pharmaceutical units.

To finalise the rules, the government has invited objections and suggestions on the draft amendments within 30 days. According to the Mint report, details have emerged on how these policy changes will impact the healthcare and medicine market in India.