Revised Schedule M and its impact on SSIs

Abstract:-

Schedule M of Drug and Cosmetics Act deals with various requirements for the manufacturing of drugs and pharmaceuticals, which includes GMPs. GMPs stands for good manufacturing practice and they are essential for producing quality products. The current Schedule M is based on 1982 WHO GMP guidelines.

 According to the revised Schedule M guideline all pharmaceutical units are required to ensure that their air and water handling systems are of high standards, control systems are in proper place and documentation is maintained. The time limit to implement these guidelines has now been extended to July, 2005. Each industry requires nearly 1-2crores of capital investment. In India there are three thousand SSI’s (Small Scale Industries) size and it means six thousand crore dead capital investment. This overnight application of Schedule M is the major problem for the SSI’s. There was an exodus of companies to excise free zones. The companies that were not in excise free zone started getting comfortable with outsourcing manufacturing to companies that were in these sectors. Thus, without having a factory they were enjoying the benefits of the excise free regions. On the other hand their new requirements will allow Indian pharmaceutical companies to expand from non-regulated to regulated markets. This change will also bring about new outsourcing opportunities both in generic and branded products for the regulated markets. While most of the large and medium pharmaceutical companies are restructuring and upgrading their facilities not only in compliance with Schedule M but also to international standards, small units do not have the resources to implement the Schedule M requirements. In this review revision of Schedule M and its impact on Small Scale Industry are discussed.

Issue of attenuation of schedule M

The Government has amended the Good Manufacturing Practices (GMP) outlined in Schedule M to the Drugs and Cosmetics Rules to ensure that manufacturing units comply with the WHO and international standards of production. Under the amended rules, it has been decided that the ancillary area requirements for plant and equipment for manufacture of majority of formulations have been deleted. Certain changes in the air handling system have also been made apart from certain other minor changes to streamline the requirements. The State licensing authorities have been given discretionary powers to modify the requirements in respect of certain categories of drugs if they are satisfied that it is necessary to relax or alter the conditions in the particular case which may be recorded in writing. The provisions of the revised Schedule will now be applicable to all the manufacturers from July 1, 2005. Health ministry not only rescinded the suspension of the three units but also allowed these units three years’ time to act in accordance with their GMP norms. The Health Ministry had suspended the manufacturing licenses of CRI Kasauli, PII Coonoor and the BCG Vaccine Laboratory Chennai on January 15, 2008 for non-compliance of GMP norms. After the Health Ministry's decision to revoke the suspension of all the three PSU vaccine units, the SSI pharma associations have been demanding to the government to relax the norms for them. Their demands stem from the argument that when the government itself, with its vast resources, could not comply with the GMP norms for its institutions for the last several years, how can the poor SSI units can comply the norms, that too without any support from the government.

Since 2005, the government introduced the inflexible Schedule M norms, the SSIs, have been seeking for the dilution of the norms and for allowing more time to comply with the norms along with some financial assistance from the government to upgrade their units to meet the rigorous Schedule M norms. After seeing the governments ‘delay on the issue for several years, hundreds of SSI units across the country closed their units as they could not comply with the Schedule M norms. As it involved a huge amount and it was beyond the capacity of the SSI units.SO most of the SSIs have been demanding to relax the rules like space requirements, air handling units and lengthy documentation in the revised schedule M. The SSIs are particularly upset over the mandatory space requirement, air handling units and documentation of all the procedures, various materials used in the production. They found that where WHO GMP is silent on space stipulations, The more rigid Schedule M has specified spaces for each section namely injectables, tablets, syrups and capsules, etc. irrespective of the fact whether it is SSI or large units. All this made the Schedule M an intolerable for most of the small scale industries which lead to the closure of various SSIs.

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