After getting stay orders on the issues of FDC and CoPP, the pharma industry may once again move court for another stay, this time the industry is contemplating to move court against the DCGI Dr Surinder Singh's practice of including several old drugs in the New Drugs List which prevents the manufacturers from getting licences from the state drug authorities.

Sources in the industry said that the industry, especially the small players, are seriously contemplating to move court against the DCGI's new practice of including old drugs like diclofenac+paracetamol combination in the New Drugs List, despite several industry associations objecting to the practice.

Industry sources 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, amenorrhoea, etc. It is an OTC drug.

There are several other drugs such as terbutaline+ambroxol, pregabalin capsules, etc which the DCGI has put in the New Drugs List. The consequences of the DCGI's practice will be costly to the industry as once the DCGI includes 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 in Delhi which attracts a lot of effort and money.

The DCGI periodically sends the New Drugs List to the SLAs and they consider the list as ‘Bible’. Under no circumstances they will give license to the new drugs and they will direct the drug companies to approach DCGI office for licenses of these New Drugs.