The next meeting of the Drug Consultative Committee meeting has been scheduled for this weekend. The main objective of the meeting is to take a close look at the key recommendations of the Mashelkar Committee pertaining to drug regulatory reforms in the country. As DCC being the official body with representation from all state drug authorities, any conclusion from the talks could lead to some key changes in the Drugs and Cosmetics Act. Dr Mashelkar has been highly critical about the disorganized system of drug control administration existing in the country in the report he submitted last year. Manufacturing licences for drug formulations are currently issued by the drug controllers of various states and Union territories with neither any coordination between themselves nor with DCGI. Many of the state drug controllers also violate the provisions of the Drugs and Cosmetics Act when they issue licences for combinations of new drugs. D&C Act clearly states that fixed dose combinations of new drugs are also new drugs and therefore has to be first approved by the DCGI. Then only state drug authorities can issue manufacturing licenses. But this provision has been more breached than followed by the state drug authorities. This is the primary reason for the existence of thousands of irrational and harmful combinations in the country today. Granting of identical or similar sounding brand names for medicines by the state drug controllers is another serious issue seeking immediate Central intervention. Such indiscriminate granting of brand names is already causing a lot of confusion amongst the patients and medical practitioners. The Mashelkar Committee has called for creation of a specific medical devices division for proper management of approval, certification and quality assurance of medical devices.

The focus of discussions at DCC, therefore, is going to be how to bring Central monitoring and interventions on the actions of state drug control agencies effectively so as to achieve a uniform implementation of the D&C Act. A key requirement in this regard will be granting of sufficient powers to the Central Drug Standard Control Organization so that it can modify existing regulatory structure or create new systems in the states where from the enforcement of all acts and rules take place. Empowering of CDSCO is also vital to periodically review the orders passed by the state drug regulators and if required to revoke the drug licensing permissions granted by them. The proposal to have an independent auditing panel to assess the performances of state drug authorities is another topic that would come for discussion. These options are being thought of, as a total shift towards a Central administration will not be accepted easily by the state governments. Considering this position, the cooperation of all state governments with the CDSCO is critical to bring about a modern and vibrant drug administration in the country.