The Fixed Dose Combinations (FDCs) should not be banned but Indian drug regulatory authority should critically review the existing fixed dose combination drugs in the market and withdraw those which do not meet these requirements, stated Dr BR Jagashetty, Karnataka Drugs Controller.
When asked to comment on the long pending issue of the 294 irrational drugs, where the issue of 80 products was still not resolved, Dr Jagashetty refrained from commenting as the matter was in Madras High Court, which is yet to be vacated.
Presently, there are no uniform principles, guidelines or standards addressing the permission for FDCs. Only a few countries have FDC regulatory guidelines available, said Dr Jagashetty.
Although FDCs are required for certain diseases, the country has witnessed an increasing number of these combination medicines which could be detrimental to public health. The big issue is that for these combination medicines, specific guidelines do not exist. This is where the drug regulatory would need to establish clear quality and safety parameters and assess the efficacy to register the fixed dose combination drugs, particularly prescription drugs, stated Dr Jagashetty while addressing the topic ‘Challenges of Regulatory Authorities in the new decade’.
Combination products for various diseases have always been prescribed by the medical fraternity. For infectious diseases like HIV/AIDS, tuberculosis and malaria, combination drugs are prescribed but with caution to prevent drug resistance. Efforts to manage these diseases include the development of fixed dose combinations of individual drugs to be administered together in one finished dosage form, he pointed out.
The key objective of the regulatory authority is to promote and protect public health by ensuring that all drugs entering the market meet the quality criteria and are safe and effective. Particular expertise of national regulatory authorizes may make valuable contribution to decisions on the cost-effectiveness and rational use of medicines with regard to pharmacoeconomics and pricing, stated the Karnataka DC.