Context: A drug advisory body sub-committee has asked pharmaceutical companies to prove that 324 combination medicines are safe and effective for patients to consume in order to decide whether these drugs should continue to be sold in India.

What’s the issue now?

• Fixed dose combinations (FDCs) were declared “irrational” by a Health Ministry expert committee set up in 2014.
• To give an opportunity to drug makers to defend the 324 FDCs, the sub-committee has given the companies until June 30 to submit and present “precise data”.

Concerns:

As of April, the CDSCO had approved 1,288 FDCs. This is disproportionately high compared with the availability in a tightly regulated market like USFDA, which has only a few hundred approved FDCs.

• The problem of unapproved FDCs mainly affects those who get treated in the private sector. In the absence of a strong pharmacovigilance mechanism in India, there is no data on adverse events of these unapproved FDCs.

What’s ailing the system?

There are multiple deficiencies in the CDSCO’s approval process for FDCs. Main amongst them are institutional problems such as understaffing, lack of skills, and inadequate infrastructure. However, the most significant issue is the issuance of manufacturing licenses by the State Licensing Authority without the prior clearance of the Drug Controller General of India DCG(I), the head of CDSCO.

What are FDCs?

An FDC is a cocktail of two or more active drug ingredients in a fixed ratio of doses. According to US healthcare provider IMS Health, almost half the drugs sold in India in 2014 were FDC, making it a world leader in combination drugs.

Why are they popular in India?

FDCs’ popularity in India is due to advantages such as increased efficacy, better compliance, reduced cost and simpler logistics of distribution. FDCs have shown to be particularly useful in the treatment of infectious diseases like HIV, malaria and tuberculosis, where giving multiple antimicrobial agents is the norm. FDCs are also useful for chronic conditions especially, when multiple disorders co-exist.