Approvals for most of the thousands of irrational combination drugs, currently in circulation in the country, were understood to have been first issued by northern states where drug administrations are generally weak with no competent officials to scrutinise such applications, it is learnt.

Once the products licences are obtained from these badly administered states, the pharmaceutical companies are free to market these products throughout the country. These irrational combinations are, thus, freely available even in strictly administered states like Maharashtra, Gujarat and Andhra Pradesh which usually disallow applications for such irrational combinations.

Informed sources said that the pharmaceutical companies have been exploiting the weakly administered states where there is hardly any administrative structure to effectively regulate pharmaceutical manufacturing and marketing. Some of these states which have been issuing product licences for irrational combinations are Bihar, UP, Pondicherry, Silvassa and Daman.

The modus operandi of the drug companies is that they will first apply for manufacturing licenses for combination drugs in these weak states. Once they receive the licenses from the state drug controller, they will market the drug all over the country for three to four years.

When the products get established with the support of medical fraternity, the drug companies will apply for manufacturing license in developed states like Maharashtra, Andhra Pradesh, Karnataka, Gujarat, etc.

As the combination drugs have been in the market for some years and are doing well, the drug controllers in these states take a lenient view in giving the product licenses for manufacturing in these states also. "If the drug companies had applied for manufacturing licenses first in these developed states, they may not the licenses as the product composition cannot pass the stability tests," a senior official in the drug control department in Maharashtra said.

There is a growing view among the senior drug officials that the DCGI's decision is provoked by the fact that pharmaceutical companies had obtained manufacturing licenses for their irrational combination drugs through this dubious way.