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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