The GMP compliance in Maharashtra is far below expectations as only around 110 out of 3,000 allopathic units and 130 out of 819 Indian System of Medicine (ISM) units in the state so far have been granted Schedule M and Schedule T certifications respectively complying with 'WHO-GMP' certification norms, said senior officials of the Maharashtra FDA. Majority of the GMP certified units are located in the cities like Mumbai, Pune and Aurangabad.
The facts confirm that neither the state FDA nor the industry is serious in adopting WHO GMP norms, which is adopted by the Central Drug Standard Control Organisation (CDSCO). The deadline for Schedule M compliance will expire on December 31, 2003. And the already extended deadline for Schedule T already expired in May 2003 and the authorities are confused about any future extension.
During the current calendar year, the FDA authorities have not been able to certify any of the units in the four states of Maharashtra, Gujarat, Madhya Pradesh and Goa, which come under the purview of West Zone of the CDSCO. "We have however inspected 150 units in these states and sent subsequent remarks to the central FDA for their perusal," said an inspector with the West Zone.
While most of the large and medium pharma companies are restructuring and upgrading their facilities not only to comply with Schedule M and T but also to international standards, small units do not have the resources to implement the Schedule M stipulations. "The small and medium enterprises (SME) and the Small Scale Units (SSI) are yet to adhere to GMP norms. The centre should arrange for some kind of financial assistance to help smaller units, who often are cash starved to carry and upgradation activity," said the FDA official.