The ban on manufacture and sale of 344 fixed dose combination (FDC) drugs including widely sold pain-killers, anti-diabetics and respiratory therapies by the Union health ministry could affect 7 per cent of domestic drug market resulting in losses of Rs.7,000 crore to pharmaceutical companies, said Pharmaceutical Wholesalers Association (PWA).

90 per cent of those which have been affected by the ban are domestic drug units, said Dilip Mehta, president of PWA.

Taking into account various taxes viz. excise duty, VAT, sales tax paid by the chemists, cost of packing materials, labour, logistics, the losses incurred by the pharma industry will reach Rs.20,000 crore, added Mehta.

The ban will have a cascading effect on growth of pharma industry. It will not only affect profitability of the drug companies but also weaken their research and development capability. The shortfall in revenue of pharma industries will subsequently lead to retrenchment of staff. Around 5000 manufacturers including MNCs like Pfizer and Abbott, and Indian companies like Alkem, Ipca Laboratories, Glenmark, Wockhardt, etc., 8,000 brands, 75,000 wholesalers, 7 lakhs drug retailers were severely affected by the ban. It is a national loss and the government has remained silent over compensation of wholesalers, retailers who stocked these drugs, said Mehta.

The stakeholders were not given sufficient time to withdraw the products from market, he rued.

He termed the ministry's decision to ban FDC drugs impractical and unacceptable which will push a large chunk of small scale pharma units into financial distress. The recently banned FDC drugs have been in the market for years and a large number of patients benefited from them.

Mehta said that manufacturers had taken necessary approvals from drug regulators to sell the said FDC medicines. If the medicines had no therapeutic value, how did the companies get licence to manufacture and sell the drugs in market, he asked.

The drug regulatory body has no sufficient mechanism to ensure withdrawal of banned FDC drugs from market. Hence the government should withdraw ban on FDC medicines in the interest of all stakeholders, he stated.