Pharma association moves court against FDC ban, traders to approach the court later

FOSIPMA, a federation of pharma manufacturers associations in South India, alleges that the decision to ban 344 drugs is baseless

The pharmaceutical manufacturers in South India are approaching the Madras High court against the Union Health Ministry's ban of 344 fixed-dose combination (FDC) drugs. The Federation of South Indian Pharmaceutical Manufacturers Association (FOSIPMA), a federation of pharmaceutical manufacturers of all the southern states, has filed a writ petition in the Madras High Court and some other associations are waiting for the result of this petition before moving ahead with their petitions.

Interestingly, the Tamil Nadu Chemists and Druggists Association (TNCDA), an association which claims a strength of 30,000 pharmacy retail members in the state, is also planning to move the High Court this week, seeking stay on the ban to make the process of returning the existing stock to the manufacturer easy. The association said that it welcomes the ban and it has been a decision long pending. According to reports, the All Kerala Chemists and Druggists Association (AKCDA) has already received an order from the Kerala High Court issuing a stay on the ban for two weeks.

FOSIPMA, which filed the writ petition on Friday, alleged that the decision to ban 344 drugs has been taken without proper study and consideration, seeking the Court to revoke the ban and also issue a stay for immediate relief.

"All the manufacturers are going to be affected because of the ban. It should also be considered that many of these medicines has been in the market for several decades and no patient has been affected because of them," said B Sethuraman, president, FOSIPMA. He added that the doctor now have to write several number of medicines instead of one earlier and in many instances, it could create difficulty to the patient.

J Jayaseelan, chairman for Indian Dru Manufacturers Association (IDMA) State Board for Tamil Nadu, Kerala and Puducherry also said that the association is watching the situation and may move to the court depending upon the developments.

"Government's order to ban 344 FDCs enbloc is arbitrary and unfair. Even though vague show causes notices without details were received in some cases, no opportunity for personal hearing has been given to any manufacturer. The many issues raised by manufacturers in reply to show cause notices have also not been answered by the Govt. and it is clear that Govt. has not applied its mind to merits of each case when issuing the enbloc order barring 344 FDCs in one go," said S V Veerramani, national president, IDMA.

The TNCDA, on the other side, feels that while the ban is a right move and has been long pending, it did not give enough time for the retailer to deal with the stock they have with them.

"We have to find out all the brands which comes under the FDC ban and inform our 30,000 or above retailers so that they can return the stocks to the company and get the credit issued from the wholesaler," said S Ramachandran, president, TNCDA. There would be several brands with the same combination. He added that there could be around 200 such different products stocked in a small pharmacy and the number could go up if it is in larger cities.

He said that around 15 companies including domestic and multinational majors have conveyed in writing that they will take back the stocks from the retail outlets and give them credit. The association has already made a list of 4,000 medicines which come under the FDC list, however, has to finalise it in the wake of several companies getting stay order on the ban from various courts. The retailers are also not sure whether they can sell the drugs though there is a stay on the ban and have stopped selling the products from the last three to four days. The pharmacists also require time to spread awareness among the customers, for medicines which has to be consumed for lifestyle disease like diabetes. The patients has to go back to the doctors and get a new drug prescribed, before changing the drug.