Apparently perturbed over the drug controller general of India (DCGI)'s recent directive to the state licensing authorities (SLAs) on the Fixed combination drugs (FDCs), the small scale pharma companies in the country have sought clarifications from the government about the status of the FDCs which were granted before 17.8.1999 by the SLAs when DCGI was not the designated authority.

The DCGI had issued a directive to the SLAs on 15.1.2013 in which the DCGI had  mandated that all FDCs permitted by the SLAs before 1-10-2012 which do not have the prior approval of the DCGI office should be cleared by the DCGI office within 18 months.

Annoyed by the directive, the SME Pharma Industries Confederation (SPIC), which largely represents the SSIs in the country, shot off a letter to Prime Minister Dr. Manmohan Singh, urging to intervene in the matter for getting a suitable clarification from the DCGI about the status of the FDCs which were granted before 17.8.1999 by state licensing authorities (SLAs) when DCGI was not the designated authority. Till 17.8.1999, Section 122-E of the Act vested powers with the SLAs to grant New Drugs where after it was amended on 17.8.1999 and DCGI was empowered instead.

Citing an instance, the SPIC said that permissions to manufacture FDCs like Glycodin and Benadryl cough syrups were granted decades before DCGI became the approving authority. No exception has been made by DCGI to such drugs in his latest directive. “Since the directive is mandatory, it can be safely presumed that policy has been got framed by MNCs/ other large pharma units once again to wrest business from SMEs knowing full well that they do not afford to spend lakhs of rupees for approval from DCGI,” the SPIC in its letter to the PM said. The second purpose is to get exclusive manufacturing rights for these FDCs four years as per Section 122-E, it further said.

According to industry sources, 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. 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 for 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.

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 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 which the SSIs cannot afford, sources said.