The All India Drug Control Officers Confederation (AIDCOC) has decided to oppose the Drug Price Regulation and Control Bill (Act) 2006, in place of Drug Price Control Order, for lack of clarity and for overlapping with various provisions under the Drugs and Cosmetics Act.

AIDCOC sources said that the new bill, if passed without major changes, will result in formation of a parallel approval system to Central Drugs Standard Control Organisation (CDSCO) under the C&F ministry with major dilution of punishments. The overlapping of various clauses in the draft bill with the D&C Act is feared to result in clashes between the two authorities, informed sources said.

The major objection to the Bill is that while the current norms ensures a severe punishment of Seven year imprisonment with unlimited fine for any kind of violation of DPCO, the Bill recommends a fine of Rs 500 per day or suspension or withdrawal of permission for marketing the product. The recommendation to charge a fine of Rs 500 per day itself lacks clarity, as the bill does not specify the cause of charging fine per day.

Further, sources added that the authority for suspension or withdrawal of a specific product is under the CDSCO and the overlapping of the clauses will add serious troubles to the related departments, as various issues due to the lack of co-ordination between the C&F ministry and the Health and Family welfare ministry are already there in the departments and the pharma industry.

While replicating many of the clauses from the DPCO the bill carries instructions on labelling, which has not been under the purview of drug price regulatory or control mechanism till date. The bill has recommendations to constitute a number of committees and advisory boards without specifying their role, besides lack of options to cover Homeopathic or ISM drugs, which may be a need in the future. The AIDCOC sources pointed out that the issues should have settled before finalizing the bill, as it needs an amendment to make further changes once the bill gets enacted.

The Confederation also alleged that the government has issued draft to the drug control officials with providing enough time to reply, while the opinion of the drug inspectors is essential to avoid technical and practical flaws. The executive meeting of AIDCOC has decided to submit a representation with controverts soon, sources said.

As Pharmabiz reported, the bill, if passed in its current form will enable C&F ministry to have a say in the marketing approval of drugs, an exclusive domain of the CDSCO of the health ministry.