The Drugs (Price Regulation and Control) Bill (Act) 2006 proposed by Ministry of Chemicals and Fertilizers (C&F) may have serious impact on the implementation of several important provisions of the Drugs and Cosmetics Act and Rules administered by the Union Health Ministry. 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 Central Drugs Standard Control Organisation (CDSCO) of the health ministry.

It is quite unlikely that the draft is to get through with the proposed clauses, it is feared.

According to official sources, C&F ministry, through the proposed draft is attempting to grant its designated authority a say in the powers to approve a brand name for a specific product to prevent changes in the composition of a product without changing the brand name. It is also known that the draft bill proposes to impose control over the production and distribution of any drug in the country in case of any emergency situation.

The health ministry feels that these provisions come under the exclusive domain of the D&C Act and any changes, if required can be effected only through an amendment to D&C Act and Rules.

Meanwhile, the C&F ministry is known to have proposed National Pharmaceutical Pricing Authority (NPPA) as the designated authority to have control over the supply of drugs. Official sources informed that the manufacture, sale and distribution of drugs are controlled as per the D&C Act and Rules and supply of drugs becomes integral part of its activities. According to them, CDSCO and state drug departments can only be in charge of such an activity.

The draft bill is also known to be having technical mismatch with the definitions given under the D&C Act. For instance, the definition of 'formulation' is not in consistence with the definition given in the D&C Act and Rules.