Good Manufacturing Practices were made applicable to the pharmaceutical manufacturers as per Schedule M of the Drugs and Cosmetics Rules, 1945 and the health ministry in its notification dated 11.12.2001 substituted Schedule M to the Drugs & Cosmetics Rules, 1945, laying revised requirements of GMPs relating to premises, plant and equipment needed to be evolved by the manufacturers of drugs
There is a general perception among the international pharma community that India is also a major contributor of spurious or sub-standard drugs floating in the global markets. Though it is a fact that lack of adequate infrastructure and personnel with the Indian drug administration at the Centre and state level is a hindrance in effectively checking the fly-by-night drug manufacturers, India has brought in adequate laws to punish spurious drug manufacturers and has mandated quality norms for drug manufacturing.
The Indian Government and its drug regulatory authorities had actually initiated measures to marginally improve the quality standards of drugs manufactured in India, way back in 1989. Good Manufacturing Practices were made applicable to the pharmaceutical manufacturers as per Schedule M of the Drugs and Cosmetics Rules, 1945 and the health ministry in its notification dated 11.12.2001 substituted Schedule M to the Drugs & Cosmetics Rules, 1945, laying revised requirements of GMPs relating to premises, plant and equipment needed to be evolved by the manufacturers of drugs. The Schedule gave general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for various categories of drugs. Certain categories of drugs such as chemicals & pharmaceutical aids, gauzes & bandages, medicinal gases, empty gelatin capsules, non chemical / mechanical contraceptives, diagnostic kits & reagents, medical devices, new dosage forms & their delivery systems, disinfectant fluids, antacids, raw-materials, and others are not listed in this schedule.
The Revised Schedule M was to apply to the existing manufacturers existing on 11.12.2001, with effect from 01-01-2004 whereas the new requirements were to become applicable with effect from 01-01-2002 for any new licensee.
It was estimated that the country had about 9,000 drug manufacturing units, majority in the small scale sector, contributing about half of the drug production in the country. Small scale drug manufacturers, mainly unorganised, protested to the mandate citing the companies would have to invest heavily, from Rs 60 lakhs to Rs.One crore to meet the requirements. Banks were not supporting to give financial assistance, and the market conditions were against them. Further, stipulations like minimum requirements on air handling system and ancillary area were practically impossible to implement.
Considering all these aspects, the Ministry of Health & Family Welfare in its notification dated December 30, 2003, extended the implementation of revised Schedule M by one year to January 01, 2005 and later another extension was given for a period of six months upto 30th June 2005.
According to rough estimates, about 2000 to 4000 units will have to close down for not complying with the Schedule M norms. The state drug controllers, the enforcing agencies in each of the states, are now in the process of assessing the level of GMP compliance by the small-scale units. The Gujarat Food & Drug administration of the Gujarat state, which produces 45 percent of the pharmaceutical production in India, has already asked 200 odd units out of about 940 Schedule M applicable units in the state to close their units until complying with the norms. Similarly, Maharashtra, which has the largest concentration of units next to Gujarat, is also in the process of closing down units that have not complied with the norms. It is estimated that about 200 drug units in the state are yet to comply with the norms. Similarly, major drug producing states like Andhra Pradesh, Tamil Nadu, Madhya Pradesh, Karnataka, Punjab, Haryana, West Bengal etc. are also in the process of assessing the level of compliance, to initiate action against rule violated units.
In a similar initiative, the Ministry of Health and Family Welfare had mandated Schedule T of the Drugs & Cosmetics Act with a deadline up to 31st December 2002 to enforce GMP norms mandatory for drug manufacturing in the field of Indian Systems of Medicine. By this, around 420 units were asked to close down in Gujarat alone. Other states are also in the process of strictly enforcing the rule and this has helped closure of numerous units in the country with substandard manufacturing facilities