The Drugs Controller General of India's move against fixed dose combinations (FDC) has turned out to be a major blow to a large number of large, medium and small pharma companies in the country. It is almost certain that pharma companies will have to discontinue sales and manufacturing of these profitable products belonging to 294 combinations in a few weeks time.

In all there are 262 brands belonging to major therapeutic segments such as orthopedics, gastrointestinal and analgesics but classified as 'absurd, banned and rejected' in the list of DCGI. There is no chance for these products to remain in the market.

According to sources, Mumbai-based Aristo Pharma is one of the most adversely affected firms by the DCGI's move against combination drugs, as five of its brands fall in the category of 'rejected' or 'banned'. The five brands, Aceclo-Mr, Aceclo-Sera, Osteoflex, Flexon-Mr and Stresnil, form a total market size of Rs 100 crore. However, the company refused to reveal more on the same.

The New Delhi-based Mankind Pharma Ltd tops the list with 17 products in various categories followed by Alkem 10, Zydus and Ipca eight each, Nicholas Piramal, Cadila Pharma seven each and Emcure and Ind-Swift six each. Companies like Comed Chemicals, Wockhardt, Cipla and Synthico five each, Jenburkt, Lupin and Torrent four each and Cosme Farma Labs (CFL) & J B Chemicals three each also occupy places in the list.

Aceclofenac+paracetamol+serratiopeptidase (41 brands), ranitidine+ domperidone (26 brands), diclofenac+paracetamol+serratiopeptidase (seven brands) and chlorzoxazone+paracetamol+nimesulide (five brands) are some of the leading combinations, which were categorized as rejected, banned and absurd by the DCGI.

Dolokind-Mr, Dolokind-Aa, Nurokind Hart, Cefakind-Oz, Gudcef-XI and Raniom-Old-Mankind are some of Mankind's brands, which were rejected by DCGI. When contacted a senior Mankind official, said, "The products, which are in the DCGI's list, do not contribute to a substantial share of our total sales. Now we are in the process of changing some molecules of these combinations and the future course action will depend on the court verdict on this issue."

Commenting on the issue Manjit Singh, vice-president, marketing, Comed Chemicals, said, "Those brands, which were banned by DCGI, are fast growing products and they contribute five per cent to our revenue."

A senior official of Cosme Farma Labs, commented, "The DCGI's move will not affect our company, as these combinations do not form a very large market. We are talking to DCGI and some of the brands are available even in the international market". It is learnt that the combinations drugs, which fall in DCGI's 'hit list', contributes nearly Rs 5 crore to Indoco Remedies.

S P Maitra, director, domestic operations, JB Chemicals, said, "It has an effect on the company, as three of our brands (two combinations) are in the list. The total market size of aceclofenac+paracetamol+serratiopeptidase is more than Rs 100 crore."

An Alkem source said that the company has already discontinued many of the brands that fall in the list even before the DCGI has taken any action. It has also re-launched some of the products by making therapeutic changes. Only four or five minor brands of the company are affected by the DCGI's move, which has a market size of Rs 6 to 7 crore.

When contacted, A K Jain, executive director, Ipca Laboratories, said, "The DCGI's move does not have any impact on us. We have already discontinued many of the brands, which are in the list. It affected only one or two brands and we are working on those brands by conducting clinical trials. We have already submitted documents of some products to the DCGI and the rest will be submitted shortly."

In an email reply to Pharmabiz, Dr Swati Piramal, director, Strategic Alliances & Communications, Nicholas Piramal India Ltd, stated, "Nicholas Piramal does not have any products in the banned or absurd lists and so there is no question of stoppage of production. There are some mistakes in DCGI list, which we have clarified as we have DCGI approval on some of them. We have a range of vitamins and DCGI has clarified that they needs only stability data that we are providing. Products containing lacto bacillus have now been mandated to have specific dosages (increased to 5 billion spores) and we will conform to the same. Nicholas Piramal will follow all regulatory guidelines given by DCGI. The sales of our products are not likely to be affected."