Product licences granted by various state drug authorities are understood to have crossed the one lakh mark in the country. Last estimate of products licensed by the state drug authorities was in the region of 60,000 including several irrational combinations.

According to regulatory officials, the pharmaceutical companies are rushing to the state drug authorities to obtain maximum number of drug licences anticipating an imminent tightening of control and procedures in sanctioning drug licenses in future. A centralised system of drug licensing to regulate mushrooming of drug brands is expected to be implemented in the country very soon.

Sources told Pharmabiz that though exact statistics are not available, the trend of increased drug registrations is taking place mostly in lesser-known pharma hubs. For example, a small state like Kerala, having less than 30 active pharma companies, has given more than 500 product registrations in the last few months. The Kerala market is flooded with over 32,000 drug brands, including 5000 odd propaganda cum distribution drugs. Senior drug officials in that state say most of these registrations are from loan licensee units of multinational and major pharma companies.

According to the director, Goa Food & Drugs Control Administration (FDA), the state licensed about 3000 drugs in 2004-05, in comparison to only 1000 odd during 2000-01.

On an average the leading pharmaceutical hubs like Maharashtra and Gujarat receive 10 to 15 drug registration applications every day.

A senior Gujarat FDA official, said, "Rules will not permit us to deny permission whether 15 applications come for the same drug. Normally big companies keep drug registrations for numerous drugs even though they will not manufacture all the registered drugs."

In Gujarat, powers to license drug registrations have been delegated to deputy commissioners and new drug applications have to go through the commissioner. In the case of Maharashtra, about seven departments handle manufacturing and distribution licensing of various drugs.

Sources said the current trend of increased drug registrations is in contrary to the sharp fall in applications in the recent times due to some policy decisions. With the implementation of MRP-based excise duty, most of the major pharma units severed business relationships with their loan licensees in various states and developed own manufacturing facilities in excise free zones. Similarly, the government put into effect a steep increase in drug registration charges from Rs 50 to Rs 300, amending the Drugs & Cosmetics Act, which forced many small scale pharma units to abandon the habit of registering numerous drugs, while actually producing only 10-20 products.

Top companies already have very large number of products and they continue to apply for more product licences every month. For example, a company like Cipla has more than 80 bulk drugs and 410 odd prescription brands, plus numerous other category drugs in its basket. Another Mumbai-based company, Sun Pharma has more 200 prescription drugs.