Industry may move court against DCGI's inclusion of old drugs in New Drugs List

Annoyed over the drug controller general of India (DCGI) Dr Surinder Singh's practice of including several old drugs in the List of New Drugs which prevents the manufacturers from getting licences from the state drug authorities, the industry is seriously contemplating to move court to get some solution on the issue.

Sources 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 List of New Drugs, despite several industry associations objecting to the practice. The industry is all the more annoyed over the fact that even though the industry had made representations to DCGI in this regard, there has been no response from the DCGI so far. “Unless relief is provided immediately, there will be no choice but to move court,” a senior industry leader said.

Several drugs being produced for decades including the time tested and commonly used Diclofenac + paracetamol tablet combination have been approved as 'new drug' by the DCGI for new symptoms. But they are uploaded on CDSCO website on the common list without specifying that they have been approved for new symptoms and SLAs may permit it for old symptoms with the result that many SLAs simply refuse to allow these drugs and SMEs feel deprived unnecessarily, sources said.

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-steroid 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 dysmenorrhea, 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 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 they will direct the drug companies to approach DCGI office for licenses of these New Drugs.