A row is heating up between the central and state drug authorities over the clearance of applications for manufacturing licences of fixed dose combinations in the country. The state drug departments are blaming DCGI and the CDSCO for not having a system of informing state departments about approved drugs and drug combinations. CDSCO, on the other hand, claims that the list of already cleared drugs and fixed dose combinations are sent to the state departments every quarter.
As there is no practice of regular coordination between state and central drug departments while issuing licenses for drug products under the present system, both the authorities are, in effect, unaware about each others product approvals, says a senior official in a state drug control department. Although, the new drug approvals are dealt at the DCGI office only, till recently there was no restriction on state departments to grant manufacturing permission for fixed dose combinations of existing drugs.
This lack of coordination between the Centre and States is posing as a serious issue among the various State departments now. At the same time, drug combinations cleared by a State can be marketed throughout the country. "If I deny license for manufacture of any fixed dose combination in my state as it is found irrational, the applicant can go to any other state and get the license and start manufacturing the same for markets across the country including my state," complaints a state drug commissioner.
Moreover, the state officials asked, as there is no official list of already permitted or permissible combinations made available by the DCGI, how they would expect the state to know while using its licensing power. "If a manufacturer applies for manufacturing license for a combination product of existing drugs along with evidences of same combinations approved in the country, no way the department can deny the same unless he is ready to prove the irrationality of the combination with supporting documents," says another licensing officer at a state FDA.
However, the Central department argues that every drug department has its discretionary powers to decide whether the license for combination drugs has to be granted or not. And the officer should use his expertise and knowledge in pharmacology to decide the drug combination for which the application is submitted is rational or irrational," says a drug controller in the CDSCO. The law at present insists DCGI's no objection certificate to be produced for a combination product license from the State in case the product is approved by the Centre within four years. But, this rule is also been flouted by many of the states, says a CDSCO official.
The debate on licensing fixed dose combinations by states without the knowledge of Centre was ignited by a recent admission of the Central government that there are a large number of unapproved nimesulide formulations present in the country in an affidavit submitted before the High Court of Delhi.
In the affidavit, the centre said that most of these drugs were approved by the state drug control authorities and cannot, prima faci, called "illegal drugs". The reason for the state level approval for new drugs, is on account of certain anomalies existing in the Drugs and Cosmetics Rules. The Centre's admission came during a recent hearing of an SLP, which sought the withdrawal of nimesulide formulations from Indian markets.