With the six months' extension of Schedule M just a signature away for official endorsement, the small-scale drug sector of the country has decided to make maximum use of the time they are to be granted by the Central Government.
Well aware of the purposelessness of never ending extensions, the Confederation of Indian Pharmaceutical Industries (CIPI), the representative body of Indian SSIs will now seek clause-by-clause discussion on the amended Schedule M to make compliance a viable option for the small players in the industry.
The SSIs would ask for a level playing field to compete with the drugs majors, both within and outside the country, it is learnt. Keeping in mind that the short-term extension is not going to serve any purpose, the SSIs will once again train their guns to bring the government to the negotiating table for further dilution of Schedule M norms.
According to sources, the government has been adamant on its stand with regard to further dilutions. The centre has repeatedly clarified its position that there cannot be two sets of standards for the drug industry. The SSIs, however, feel that the government should only prescribe the minimum standards required, with the option for further sophistication left to the individual units.
The Schedule M effect has however started to trickle down the SSI sector. According to J R Agrawal, former president of M P Small Scale Drugs Manufacturers Association, the changing situation is compelling several SSI drug makers to quit drug-manufacturing business. "There are increasing instances of companies closing down their operations in every part of the country. I have sold off my 25-year old company due to increased risk in small scale pharma business", Agrawal said. Unfortunately, there is no proper data available on the exact number of companies that are up for sale or on the verge of closure.
The CIPI had stated that the Schedule M norms in its current form was to adversely effect "over 3,000 SSI units employing over 2,00,000 people, with an investment of nearly Rs 5,000 crore."