The Indian Medical Association (IMA), a national voluntary body representing 2.7 lakh doctors in India, will collate a list of combination drugs that are “irrational” and “unsafe” so that its members can avoid prescribing them.
A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.
IMA has written to Drug Controller General of India (DCGI) G N Singh after the Delhi High Court quashed a government ban on over 300 combination medicines on the ground that the government exercised power under the Drugs and Cosmetics Act without consulting the Drugs Technical Advisory Board and Drugs Consultative Committee.
In this circumstance, the government should “immediately challenge” the decision in a higher court or redo its exercise “in accordance with the provisions of the DC Act and rules made there under,” IMA’s letter reads.
“However, till that time, the innocent patients cannot be allowed to be put in danger by administration of FDCs (fixed dose combinations) which have been declared by Kokate Committee as irrationalâ¦,” the letter states.
“â¦IMA prays to the Central Government/DCGI to issue advisory in newspapers, etc. for the benefit of public at large and the doctors to the effect that the FDCs should be administered/prescribed or not.”
IMA National Presidentelect K K Aggarwal said that the IMA is also considering implementing a curb on the prescription of FDCs that have not been approved elsewhere in the world and those which its members also consider irrational.
The voluntary body is currently studying the World Health Organisation’s (WHO) list of essential medicines, which includes only 24 FDCs that are limited to treatment of TB, HIV and malaria, said Aggarwal. A few are antibiotics, he added.
India has over 2,000 FDCs available in the market, out of which only 16 are approved in India’s National List of Essential Medicines. FDCs comprise an estimated 40 per cent of India’s reportedly Rs 1 lakh crore market for drugs, according to public health group Jan Swasthya Abhiyan.