Deeply annoyed over the Drug Controller General of India (DCGI) Dr Surinder Singh's practice of approving and including several old drugs in the 'List of New Drugs', a section of the industry will soon meet senior officials in the union health ministry to apprise them of the consequences of the actions of the DCGI and also to restrain the DCGI from including old drugs in 'New Drugs List'.
Sources said that the industry, especially the small and medium sector, is annoyed over the DCGI's practice of including old drugs in the 'List of New Drugs' as that prevents the manufacturers from getting licenses for these drugs from the state drug authorities.
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 so 'called' New Drugs, sources said.
Sources said that several drugs being produced for decades including the time tested and commonly used diclofenac + paracetamol combination (analgesic, antipyretic tablets) 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.
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 largest 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.
Some of the other such drugs which have been approved as 'new drug' by the DCGI included ambroxil with terbutaline (cough syrup), Clindamycin tabs (antibiotic) and Betahistine tablets (for Meniere's disease). There are several other drugs such as terbutaline+ambroxol, Pregabalin capsules, etc which the DCGI has put in the New Drugs List.
Meanwhile, a section of the industry contend that after the introduction of Schedule M and MRP-based excise, it is one more method deployed by the vested interests to make SMEs unviable as unnecessary submission of data and fee are out of reach for many SMEs in the country.