Increased Scrutiny in India’s Pharmaceutical Business

The Drug Controller General of India (DCGI) has initiated strategies to strengthen regulatory oversight of India’s pharmaceutical industry. India expects to add about 200 more drug inspectors in the coming months to build up their drug regulatory capacity.

Previously, oversight of India’s pharmaceutical industry was deemed to be inconsistent and unreliable, largely due to the inadequate staffing of drug inspectors. Overloaded inspectors were not able to properly examine factories, often resorting to sloppy procedures and overlooking quality control issues. To combat this, the DCGI will not only recruit more drug inspectors, but also work to improve the skills of its regulators through training programs and workshops. This includes joint inspections with international regulators that will train Indian drug inspectors on global quality standards and inspection practices. In addition, the DCGI plans to ensure compliance by strengthening the punitive measures of the Drugs and Cosmetics Act.

Infrastructure will be improved to provide faster testing laboratories for drugs. The DCGI will support the implementation of new drug testing methods and advanced software in order to improve efficiency in the testing of drug samples. The Central Drugs Standards Control Organization (CDSCO) also plans to introduce 20 mobile drug testing labs. These strategies contribute to the nation’s efforts to prove that Indian drugs are not inferior in quality and that they deserve a strong presence in the global market.