The pharmaceutical industry in the country is upset over the way several drugs which have been in the market for decades are being licensed as new drug by the Drug Controller General of India (DCGI). Though the industry had taken up the issue with the DCGI in the past too, the DCGI office continues the same practice.
One such case is that of pregabalin capsules. According to sources, this product has been licensed as a new drug once again by the DCGI office solely for the new indication of fibromyalgia syndrome. Earlier, diclofenac with paracetamol tablets was approved by the DCGI office and put on the List of New Drugs. Diclofenac+paracetamol combination is one of the most commonly used medicines in the country and this combination drug has been in the market for more than 20 years. When the other manufacturers approached the SLAs for permission to manufacture the same drug, the SLAs refused to grant permission on the ground that the drug has been categorized as new drug by the DCGI office.
The consequences of the DCGI decision will prove to be costly to the industry as once the DCGI includes a drug in the New Drugs List, the state licensing authorities (SLAs) will not issue 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.
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.
Opposing the DCGI's decision to include such drugs in the list of new drugs, some pharma associations have approached the DCGI once again urging him to find some way out so that the manufacturers are not deprived of permissions from SLAs.
Since the names of these drugs figure on the List of New Drugs by DCGI, many SLAs have stopped permissions of these drugs to manufacturers all over again for a period of four years from the date of fresh licensing. Since they are not actually New Drugs, some way out needs to be found out to ensure manufacturers are not deprived of permissions from SLAs.
To clear the confusion, the industry has proposed that in cases such as mentioned above, permissions may be granted under a separate Heading which clearly specifies that they are not really New Drugs so that SLAs do not stop permissions after lapse of initial four years of exclusivity.