Tuesday, 15 March 2016

Fixed drug combinations banned: the matter in the court

Fixed drug combinations banned: the matter in the court
Dr K K Aggarwal

The Delhi High Court has granted U.S. pharmaceuticals giant Pfizer Inc's India unit a stay on a government ban on its popular cough syrup Corex chlorpheniramine maleate and codeine).
The ban on Pfizer's cough syrup was part of a wider notice issued by the government ordering prohibition of the sale and manufacture of 344 combination drugs that a panel of experts found posed a risk to humans. The next hearing by the Delhi High Court on Pfizer's plea is slated for March 21.
Health ministry banned the combination of chlorpheniramine maleate and codeine syrup. The court said the government had not issued Pfizer a "show cause notice" before banning the medicine.
The ban also applied to Abbott Laboratories' Phensedyl cough syrup and Abbott's Indian subsidiary also filed a writ petition at the same court, which will come up for hearing on Tuesday.
A panel of experts found the drugs lacked "therapeutic justification".
The sale of fixed dose combination medicines in India requires the approval of the central government. But several drug combinations have entered the market over the years based solely on approval from individual states.
In 2007 it ordered states to recall about 300 such combination drugs, but drug makers challenged it in court and the order was stayed.
In 2014, India set up a panel of experts to review over 6,000 such drug combinations, and asked companies to submit data to prove safety and efficacy of their drugs. 344 of those have been banned.
Standard Notification for all drugs
NOTIFICATION New Delhi, the 10th March, 2016 S.O. 983(E).—
Whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Chlorpheniramine + Codeine Phosphate + Menthol Syrup is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
 And whereas, the matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said drug is found to have no therapeutic justification;
And Whereas on the basis of the recommendations of the said Expert Committee, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug fixed dose combination of Chlorpheniramine + Codeine Phosphate + Menthol Syrup with immediate effect.
[F. No. X-11035/53/2014-DFQC] K. L. SHARMA, Jt. Secy.

   

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