Doctors Body May Collate List of `Unsafe' Combo Drugs


IMA plans move after Delhi HC quashes govt ban on over 300 combination drugs

Now that the Delhi High Court has quashed a government ban on over 300 combination medicines, a body of doctors has asked the central drug regulator whether these medicines are unsafe and shouldn't be prescribed. The body also said it may collate its own list of combination drugs that are “irrational“ and “unsafe“ to prescribe.

The Indian Medical Association (IMA), which represents over 2 lakh doctors, wrote to Drug Controller General of India (DCGI) GN Singh after the Delhi court's verdict, people familiar with the development told ET.

IMA's letter suggests that the ban notifications were quashed on December 1 mainly over procedurerelated issues ­ that the government exercised power under the Drugs & Cosmetics Act without consulting the Drugs Technical Advisory Board and Drugs Consultative Committee.

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 thereunder,” IMA said in the letter, a copy of which was seen by ET.

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 irrational,” the letter stated. “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.”

Combination drugs contain two or more therapeutic ingredients packed in a single dose.

According to IMA national president-elect KK Aggarwal, the body is also considering implementing a curb on the prescription of combination drugs that have not been approved elsewhere in the world and those that its doctors consider irrational.

IMA was a party to the proceedings in the Delhi High Court and had supported the ban.

IMA is studying the World Health Organisation's list of essential medicines, which includes 24 combination drugs that are limited to the treatment of TB, HIV and malaria, said Aggarwal. A few are antibiotics, he added.

We'll wait for DCGI's response first. In the meantime, we've written to all doctors asking for a list of FDCs they feel are irrational, which they feel IMA should put as an advisory,” Aggarwal told ET. FDCs are more expensive and have more side effects and the potential for underor overdose than medicines with single therapeutic ingredients, he said.

DCGI did not respond to ET's emails and phone calls seeking comment on IMA's letter. Over 2,000 FDCs are available in India, government sources told ET earlier.At the same time, only 16 FDCs are approved on India's National List of Essential Medicines.

FDCs comprise an estimated 40% of India's `1 lakh crore market for drugs, according to public health group Jan Swasthya Abhiyan.The ban that was set aside by the court had affected about 6,000 brands, including popular medicines such as Corex, D'Cold and Saridon.

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