India is called the 'pharmacy of the world', but repeated drug-quality failures have damaged its credibility. Discuss the regulatory reforms undertaken and the gaps that remain.

India regulates drug quality under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. CDSCO and the State Drugs Controllers share enforcement. After the cough-syrup contamination episodes, the government brought in a series of reforms. However, enforcement capacity has not kept pace with them.

Regulatory reforms undertaken

• Revised Schedule M (G.S.R. 922(E), 2023): added a Pharmaceutical Quality System, Quality Risk Management and validation. This brings Indian GMP closer to global standards [2].
• Phased compliance: binding on firms with turnover above ₹250 crore from June 2024. Smaller firms got a conditional extension to December 2025 [3].
• Risk-based inspections: CDSCO and the States inspected 400 premises, including MSMEs [2]. More than 960 such inspections have been carried out since December 2022 [8].
• Retail tightening: G.S.R. 927(E) (2025) allows cough syrups to be sold only through licensed pharmacies [4].
• Individual accountability (draft, 2026): every manufacturer must name a qualified authorised person for batch release, keep records for every batch and issue a Batch Release Certificate [1].

Gaps that remain

• Inspector shortage: CAG found 88% of drugs inspector posts vacant in Karnataka [5]. Punjab had only 52 of 120 required inspectors in post [6]. The Mashelkar Committee had asked for more inspectors long ago [9].
• Late testing: in Karnataka, 59% of drugs were consumed before their test results arrived [5]. Finding a batch NSQ then only fixes blame; it does not prevent harm.
• Weak central capacity: the Parliamentary Standing Committee (2026) flagged persistent Drugs Controller vacancies. It also said CDSCO's generalist set-up cannot handle complex technical evaluation [7].
• MSME strain: smaller firms needed more time for Schedule M [3]. A new compliance post adds to their costs.
• Design of the draft rule: the manufacturer names the authorised person, and the draft as reported does not address independence or recall duties [1].

Way forward

• Fill vacancies on a fixed timeline, create a specialist CDSCO cadre and empanel more testing labs [7].
• Make the authorised person independent of production and testing, and link certificates to recalls.
• Give MSMEs technical and financial support to upgrade.

India has moved from batch control led only by the regulator to layered quality assurance: GMP standards, risk-based inspections and named accountability. Backing these rules with enough inspectors and testing capacity will turn compliance on paper into real assurance. That will protect the right to health under Article 21 and restore India's credibility as the pharmacy of the world.