Recent amendments to the Drugs Rules, 1945 seek to shift drug quality assurance from regulator-led control to manufacturer accountability. Critically examine.

Under the Drugs and Cosmetics Act, 1940, drug quality has mostly been checked from outside the company. The licensing authority can hold a batch until it certifies the batch for sale [1]. Two recent changes move this responsibility inside the firm: the revised Schedule M of 2023 [2] and the 2026 draft rule requiring an authorised person for batch release [3]. The shift is real, but it is not complete.

Strengths: moving towards manufacturer accountability

• One named person: licences now list only general technical staff. The draft makes each firm name one qualified person to release batches, supported by batch records and a Batch Release Certificate [3].
• Quality systems, not just final testing: revised Schedule M adds a Pharmaceutical Quality System, risk management and validation. It became binding on large firms from June 2024 [2][4].
• Global alignment: WHO GMP requires an "authorised person" to certify every batch before sale [5]. This supports India's credibility as an exporter.
• Patient safety: after the cough-syrup episodes, a final named checkpoint adds to other curbs, such as G.S.R. 927(E), which limits cough-syrup sales to licensed pharmacies [6].

Limitations: accountability without independence or oversight

• Conflict of interest: the firm appoints and pays the person who approves its batches. Under WHO GMP, the national regulator recognises this person [5], and WHO guidance bars staff from releasing batches they made or tested [7]. The draft says nothing on either point.
• No duty after release: the certificate is not linked to recalls, which WHO GMP makes the authorised person's job [5].
• Weak enforcement: CAG found 88% of Karnataka's drugs-inspector posts vacant, and 59% of drugs were used up before their test results arrived [8]. In 2026, the Parliamentary Standing Committee on Health flagged persistent vacancies among Drugs Controllers [9].
• Burden on MSMEs: smaller firms needed a deadline extension to December 2025 just to meet Schedule M [4]. A new named post adds cost.

Overall, the amendments add manufacturer accountability on top of regulator-led control; they do not replace it. The final rule should require independence, keep a CDSCO register of authorised persons and link certificates to recalls. Inspector posts should be filled on a fixed timeline, as the Standing Committee urged [9]. With these fixes, a named signature can help deliver safe medicines, part of the right to health under Article 21, and restore India's standing as the "pharmacy of the world".