CDSCO reiterates strict batch-wise testing of raw materials and finished formulations

India's central drug licensing authority, CDSCO has directed State and UT Drug Controllers to strictly enforce the testing requirements under the Drugs Rules, 1945. The manufacturers are required to test every batch of raw materials, including active pharmaceutical ingredients and excipients, in their own laboratory or a laboratory approved by the Licensing Authority. This includes critical excipients such as propylene glycol, glycerol and sorbitol. Every batch of finished formulation must also be tested, with records maintained as prescribed under Schedule U. The latest direction reinforces inspections, vendor qualification and sourcing from reliable, approved suppliers. Manufacturers should ensure documented batch-wise testing and compliance before releasing products into the market.