Gujarat with largest number of small scale pharmaceutical units in the country, has emerged as the state having as many as 65 percent of units already complied with Schedule M norms.

The highest rate of GMP implementation in the state is mainly attributed to the various unique developmental schemes and awareness efforts initiated by both the industry and the state drug regulatory department. The developmental activities like cluster development programme, quality circle etc implemented by the industry in association with the various NGOs including the state chapter of IDMA and government agencies, were proved to be effective in successfully achieving the goal, said the industry sources.

Though the GMP implementation rate is high in the state, the Gujarat Food and Drug Control Administration (FDCA) is still of the view that barring the units, which are already in the process of being certified and even in the primary stages of standardization, atleast 150 to 200 units seem to be under the scanner for issuing closure notices, if the December 31 deadline remains unchanged.

For the units, which are yet to be complied with the standardization norms, the major reasons are inadequate finance and the fear about the uncertain return on the fresh investment. As per the revised Schedule M norms, existing units would require sizeable investment to provide proper water and air handling systems, air filtration systems etc., besides major changes in their layout including structural changes.

For this, each unit would have to spend about Rs.30 to Rs.100 lakhs to revamp their facilities. The additional huge investment by the units would not reap immediate benefits for the SSIs, which are passing through difficult time. Further, it would cause constraints in their profitability, said the industry sources.

The SSIs here generally feel that the closure move would considerably affect Gujarat, as 45 per cent of the pharmaceutical production in India was from the state, which houses more than 3000 SSI units. A sizeable number of companies were producing for exports. The units in Gujarat were contributing significantly to the national drug requirements.

However, since there is hardly any assistance expected from the state industry department, the industry association and the drug control department are seriously considering helping the SSI units to upgrade their technology and the facility to avoid the imminent death of non GMP complied units in the state.