The central government has decided to plug the existing loopholes in the Drugs and Cosmetics Act and Rules which allows the state drug control authorities to issue licenses to drugs that come under the new drug category. The government is in the process of amending the Rule 122 B of Drugs and Cosmetics Rules to effect the change, it is learnt.
According to sources, the state licensing authorities had been issuing manufacturing licenses for new drugs if the applicants’ were able to furnish sufficient proof that the drug has already been approved by the central authority.
Though the rules specify that all new drugs need to be first approved by the central drugs standard control organization (CDSCO), the rule is often bypassed for subsequent approvals under the ambiguity existing within the law. The Rule 122 B of Drugs and Cosmetics Rules only states that while “applying for approval to manufacture a new drug under sub rule (1) or its preparations, to the state Licensing Authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved by the Licensing Authority mentioned in Rule 21.” Interestingly, the intention under the Law is that the applicant should have prior approval, in writing, in favour of the applicant from the Licensing Authority under Rule 21, before applying to the state Licensing Authority for permission to manufacture the new drug and not just producing an evidence that the drug is permitted to be marketed in India.
What often happens is the contrary thereby leading to a flood of unapproved formulations (for instance, nimesulide formulations being marketed in the country without DCGI approval – but having genuine state level licenses) in the market.
The Union Health Ministry is soon to add a proviso to the rule and thereby specify that the licensing authority mentioned there refers to the central licensing authority ie the licensing authority mentioned in Rule 21 and also the applicant should produce evidence that the central authority has approved the case in the name of the applicant and not for someone else.