Indian pharma industry has the largest number of USFDA approved manufacturing facilities outside the US. Also, the plans approved under the EDQM, WHO and GMP. But the major concerns that are worrying the industry today is decline in the CAGR, non-adherence to quality standard norms, the growing competition from other countries, huge dependence on imports for the key starting materials as also the APIs, lack of R&D and discovery of new molecules, according to Dr Pallavi Darade, Commissioner, Food & Drug Administration, Government of Maharashtra.
Dr Darade was speaking at the Elets National Food and Pharma Summit organised recently in Ahmedabad, Gujarat. “The pharmaceutical industry in India is robust and thriving. The annual turnover of the industry in 2015-16 was about 200,000 crores and the exports were worth about 11 lakh crores. The domestic consumption was around 98,000 crores. The Indian pharma sector is largely fuelled by exports and is the third largest foreign exchange earner for India. It employs about 200,000 workforce across the value chain,” she said.
Pharmaceuticals is a private investment driven industry and the contribution of the Public Sector Undertakings is literally negligible.
Pharma industry in Maharshtra constitutes almost one-third of India’s production. Till 2005, Maharashtra was the leading state in the field of pharmaceutical manufacturing. However, because of the creation of special economic zones the state lost its edge in some areas but has little effect on the growth of the industry in the state.
“Maharashtra FDA nearly has about 18,000 crores of export industry. To further strengthen the base, it is essential to maintain quality standards of drugs and upgrade the regulatory norms. The pharma policy by the Government of India has already initiated such steps…The Schedule M of Drug and Cosmetics Rule 1945 was substituted completely by a revised Schedule M under GSR in 2001,” Dr Darade said.
Taking this forward, Maharashtra has made it compulsory to fill the Schedule M and submit it to the authorities. “The Schedule M defines in detail the general requirements, the water system, the disposal of waste, the warehousing area, the ancillary area the quality control area, health, clothing and sanitation of workers, etc. We are asking all industries for self compliance, self reliance and self audit. Following this decision, the DGCI has also issued similar instructions all over India, emphasising self compliance,” she added.