After Pfizer, HC grants relief to Abbott and Macleods

The Health Ministry, through a gazette notification, has banned over 300 fixed dose combination drugs, including cough syrups compositions, saying they involve "risk" to humans and safer alternatives were available.

PTI| Last Updated: Mar 15, 2016, 19:33 PM IST

New Delhi: Pharma majors Abbott Healthcare and Macleods Pharmaceuticals Tuesday got interim relief from the Delhi High Court which stayed till March 21 Government's decision banning sale of certain combination medicines of the two companies.

 

Justice Rajiv Sahai Endlaw said why cannot a similar relief, as granted to pharma major Pfizer's cough syrup 'Corex' Monday, be extended to these two companies.

"The drugs which are subject matter have been in market for over 20 years. I am of the view that a counter affidavit is required in this petitions. There is no question, why same interim relief be not granted to the present petitioners, like it was given yesterday.

"List the matter for Monday (March 21). Till then the effect of notification shall remain stayed and no coercive steps shall be taken against the stockist, retailer and the sellers qua the petitioners here," the court said.

The court also issued notice to Ministry of Health and Family Welfare directing it to file status report with regard to the findings of the expert committee set up by it following which sale of over 300 drug combinations have been banned across India with effect from March 10.

The court's order came on pleas moved by Abbott Healthcare and Macleods Pharmaceuticals who contended that no show cause notice or hearing was granted prior to the notification.

They alleged that the notification is silent on the aspect as to which expert committee was appointed by Health Ministry to examine the safety and deficiency of the fixed dose combination (FDC).

Additional Solicitor General Sanjay Jain, appearing for the Centre, submitted that the action taken was not against a company or brand centric.

"The decision was taken by the expert committee," ASG said, adding that this was done in "public interest".

This prompted the judge to note that the companies have been in market for over 20 years. "Now what has happened that all of a sudden you ban the sale of their drug combinations," he asked.

The petitions pertain to ban on sale of Abbott's Tixylix toddler syrup and Phensedyl cough syrup as well as Macleods' panderm plus ointment.

The Health Ministry, through a gazette notification, has banned over 300 fixed dose combination drugs, including cough syrups compositions, saying they involve "risk" to humans and safer alternatives were available.

The two pharmaceuticals have sought quashing of Centre's March 10 notification and urged the court to call the records including the expert committee.

Abbott in its plea said the notification has prohibited the manufacturer from selling, distributing and marketing for human use its products Tixylix toddler syrup and Phensedyl cough syrup.

Macleods in its plea said the notification has prohibited the manufacturer from selling, distributing and marketing for human use its product panderm plus, an antifungal ointment.

They said that due to the notification sales of the drugs have come to a grinding halt causing immense duress to the company as well as consumers and patients.

The company said the ban would lead to huge financial loss as well apart from exposing the company to criminal prosecution under the Drugs and Cosmetics Act.

According to the ministry's notification, "On the basis of recommendations of an 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 drugs in the country."

The 344 banned drugs include the fixed dose combination of Chlopheniramine Maleate and Codeine syrup sold under the popular cough syrup brand Corex.

Following the government ban, pharmaceutical major Pfizer discontinued manufacture and sale of Corex with immediate effect.

Fixed dose combination drugs are combinations of two or more active drugs in a single dose form.