The Central Drugs Standard Control Organisation (CDSCO) has reiterated strict compliance with the Drugs Rules, 1945, directing State and Union Territory Drug Controllers to ensure mandatory batch-wise testing of pharmaceutical raw materials, excipients and finished formulations.
Directorate General of Health Services, CDSCO emphasized that pharmaceutical manufacturers must test every batch or lot of raw materials, including critical excipients such as propylene glycol, glycerol and sorbitol, before their use in manufacturing.
The directive also makes it mandatory to test every batch of the finished pharmaceutical product to ensure compliance with prescribed quality standards.
The regulator has instructed manufacturers to establish robust vendor qualification systems and procure raw materials and excipients exclusively from reliable, approved vendors. The move aims to strengthen pharmaceutical quality assurance and safeguard the safety and efficacy of drug formulations.
As per the applicable provisions of the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945, manufacturers must maintain proper records and registers containing details of all prescribed tests, as specified under Schedule U.
The communication also refers to the earlier CDSCO advisory dated October 7, 2025, which highlighted concerns regarding inadequate testing of pharmaceutical ingredients during manufacturing inspections and investigations into substandard drug products.
CDSCO has asked all State and UT Drug Controllers to accord top priority to the matter and direct manufacturers operating under their respective jurisdictions to implement the requirements strictly.
The latest directive reinforces the regulatory expectation that quality testing must not be limited to finished medicines alone but must extend to every batch of incoming raw materials and excipients.
The communication serves as an important reminder to pharmaceutical manufacturers to review their quality control procedures, vendor approval systems, incoming material testing practices and finished-product testing records.
Strict implementation of these requirements is expected to strengthen manufacturing quality systems and improve regulatory compliance across India's pharmaceutical industry.
