Sunday, 1 January 2017

Delhi High Court sets aside Centre's decision to ban 344 fixed dose combination medicines

Delhi High Court sets aside Centre's decision to ban 344 fixed dose combination medicines

The Delhi High Court has set aside the Centre's decision to ban 344 fixed dose combination (FDC) medicines, including well-known brands like Corex cough syrup, Vicks Action 500 Extra and D'Cold, reports TOI. 

The court gave the order after hearing arguments of companies like Pfizer, Glenmark, Procter and Gamble and Cipla, the central government and some NGOs like All India Drug Action Network (AIDAN).

The court had on March 14 stayed the Centre's March 10 ban on 344 FDC drugs and this interim order was passed in each and every case filed before it thereafter.

According to the drug companies, the government has not properly implemented the powers under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act, under which the ban was ordered. The ban order was passed without considering clinical data and the grounds that safer alternatives were available. The government had banned over 300 FDC drugs on the ground that they involve "risk" to humans and safer alternatives were available.

As per the March 10 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 said drugs in the country."

The Centre had argued that the FDC medicines are "new drugs" and thus, require licence from Drugs Controller General of India (DCGI) for sale and manufacture. Also there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action at state level. However, it had also said that the lack of approval for these FDCs were a secondary issue and the primary focus was that they "lacked safety and efficacy" and thus, "ban was the only answer". According to them, the banned FDCs had no "therapeutic justification".

AIDAN, argued that there were nearly 40,000 FDC drugs in Indian market and since the regulatory control over such medicines was allegedly "illusory", the Centre's decision to ban some of them "was the only move". 

IMA View

IMA is only concerned with safety and quality of a drug. The job of DCGI is to maintain both. If the DCGI cannot take the guarantee of the quality and safety of any drug, how will doctors treat patients? 

In Malay Kumar Ganguly vs Sukumar Mukherjee & Ors on 7 August, 2009, the Supreme Court of India relied on the drug package insert, which is always cleared by the DCGI.

DCGI should either challenge the order or label these combinations as safe drugs. 

No comments:

Post a Comment