Kerala - Thiruvananthapuram   

Central directive to withdraw licences of 1,105 drug brands

C. Maya

Drugs Controller-General says these are irrational ‘fixed dose combinations’

Thiruvananthapuram: The Central drug control administration has issued a directive to the State Drugs Control Authority to withdraw the manufacture and sale licences of 1,105 brands of drugs currently being marketed in Kerala and elsewhere in the country, as these are irrational ‘fixed dose combinations’ (FDCs).

The directive was issued by the Drugs Controller-General of India (DCGI) to all State drug control administrations across the country following the Drugs Consultative Committee meeting that was held on June 4.

While the State drug control administration is yet to implement this order of the DCGI, the market implications of this Central directive is immense. If the ban were to be put into place, various brands of drugs estimated at crores of rupees will have to be taken off the shelves.

The DCGI has found some 320 fixed dose combinations to be irrational and these include several well-known brands of general, orthopaedic, anti-microbial, anti-allergic drugs brought out by several pharma giants, including Cipla, Ranbaxy, Cadila, Blue Cross, Alembic, to name a few.

However, those in the field of pharmacology have welcomed the ban. They point out that all sorts of strange combinations of drugs, some of which are not just useless but can even be dangerous, have been flooding the market. Combinations such as paracetamol and nimesulide, both of which cause liver toxicity and which have been banned in the U.S and several developed countries, are freely marketed in India.

Sources in the drugs department point out that pharma companies resort to the manufacture of fixed dose combinations to escape the drug price control order. The National Pharmaceutical Pricing Authority has fixed the price of some 74 drugs.

“The price of one drug molecule, eg., paracetamol, may be fixed. The pharma companies will add another molecule - like tizanidine or aceclofenac in combination with paracetamol and introduce it as a new drug in the market to escape the price control order. The price of this novel, combination drug may be three times the price of the original drug,” an official said.

Combination drugs should be allowed only on the basis of strict guidelines, to achieve better therapeutic effect or if one drug may help reduce the side effects of the other.

There are dangers like adverse drug reactions and dosage differences of drugs when two drugs are combined. Drugs that belong to the same group and have similar effects should never be combined.

Thus some of the irrational drug combinations that the DCGI has cracked down upon include aceclofenac, paracetamol and tizanidine; aceclofenac, paracetamol and serratiopeptidase; nimesulide, paracetamol and serratiopetidase; alprazolam and propranalol; norfloxacin, tinidazole and dicyclomine

All new molecules of drug have to be approved by the DCGI.

Once the drug has been approved, it is the State drug control administrations that issue the manufacturing and sale licences.

When two approved molecules are combined, it is clinically a new drug and requires the DCGI approval. But often, pharma companies manage to bypass this and once any State drug control administration issues a manufacturing/sale licence, the drug can be sold anywhere in India.

“The manufacturing licence for any new drug should be issued by a State DCA only if the pharma company produces the permission of the DCGI in Form 46. It is for the respective State drug control administrations also to explain how they overlooked the existing rules to allow these irrational combinations in the market,” a drug department official said.

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