The Central Drugs Standard Control Organization (CDSCO) – India’s drug regulatory will soon begin surprise inspections at drug manufacturing sites. This inspection will help the government to find out drug units that may deviate from standard manufacturing practices. CDSCO said if the drug manufacturing site is deviating from quality standards face punishment and even they may issue suspension or cancellation of licences. In other major deviations CDSCO may also take legal action against the company. Here is another interesting article related to Thai FDA takes tough action against the advertisements on health products which are illegal.

The surprise audits will be carried out by inspectors who have already been trained for the purpose with 15-20 teams of three across the country and in the first phase at least 20-30 sites will be targeted for inspection. Critical observations like safety, quality and efficacy of the products are inspected then actions initiated immediately, and reports are to be finalized at the end of the inspection.

In 2014 Drug Consultative Committee outlined areas for inspections such as establishing shelf life, validation studies and ensuring effective recall besides the WHO GMP requirements. CDSCO is also looking to strengthen the process by ensuring frequent audits and wide coverage. The regulator plans to employ 1,000 people in various groups at the Centre and state levels over the next 3 years. About 250 of them will be for the inspection. According to ICRA Ltd January report, in 2015 alone the FDA issued close to 20 warning letters to Indian firms.