The pharmaceutical industry in the country is vehemently opposing the DCGI Dr Surinder Singh's recent decision to include diclofenac+paracetamol combination in the list of new drugs. How can the DCGI include a drug which has been in the market over two decades in the list of new drugs, the industry asks.

Taking strong exception to the DCGI decsion and terming it as 'violative of his earlier assurance to the industry that no other FDCs will be brought under new drugs list', the industry associations raised the issue in the DCGI-industry meeting held on October 1 to resolve the vexed and protracted issue of fixed combination drugs. Representatives of all major industry associations like IDMA, CIPI, FOPE, SPIC, IPA, OPPI were present in the meeting.

"If somebody comes for license with supportive data, what can I do? ", the DCGI is learnt to have replied to the industry.

Sources in the industry said that the industry is both surprised and angered over the decision as the diclofenac+paracetamol combination is one of the most commonly used medicines in the country and the drug has been in the market for more than 20 years. It is also one of the highest selling medicines. It is a non-steroidal anti-inflammatory drug taken to reduce inflammation and as an analgesic reducing pain in conditions such as arthritis or acute injury. It can also be used to reduce menstrual pain, dysmenorrhoea, etc. It is an OTC drug.

The consequences of the DCGI decision will be costly to the industry as once the DCGI included a drug in the new drugs list, the state licensing authorities (SLAs) will not provide license to that drug for four years. For getting license for this combination in the next four years, the drug companies have to approach the DCGI office which attracts a lot of effort and money.

Sources said that the DCGI periodically sends the list of new drugs to the SLAs and they consider the list as 'Bible'. Under no circumstances they will give license to the new drugs and will direct the drug companies to approach DCGI office for license.

A spokesman of an industry association, who did not want to be named, said that "the DCGI is violating the sanctity of the new drugs list".