The small-scale pharmaceutical manufacturers in the country have sought a political solution to the practical difficulties they are facing to conform with the mandatory GMP as per the revised Schedule M of the Drugs & Cosmetics Act. The Associations have already sent a representation to the Lok Sabha stating their problems when the deadline for enforcing the new WHO GMP approaching.
The All India Small Scale Pharmaceutical Manufacturers Association (AISSPMA) and state level associations from Tamil Nadu and West Bengal have also started meeting Indian political leadership and individual members of the Parliament to find a solution to their problem at the political level.
According to S L Nasa, executive secretary, AISSPMA, Rajyasabha has taken up this issue and asked the association to give a report on the difficulties they face when it comes to the implementation of the Schedule M. "We had consulted all state level associations before presenting our issues before the Lok Sabha. We are expecting a political solution to it," he said.
The new GMP is to become compulsory for all pharma units from January 1 2004. While the government is holding various workshops in various states to say about the need to have new GMP, the small sector is of the opinion that the existing units should not be forced to adopt the new standards and the norms should be applicable only to the new units.
Increased license fee for manufacturing is another issue that has been brought to the notice of the authorities by the SSI sector. "The fee has been increased from Rs 800 to Rs 15,000 against which we have represented to the government, to the ministry and the drugs control department," Nasa said.
As of now, only the manufacturers in the states of Tamil Nadu and Pondicherry are still giving the old rates of license fees. The state level associations there were able to obtain a stay order on the new fee from the High Court. The industry associations in states like Madhya Pradesh and Haryana are also known to have moved the court to find a solution to the problem.