The newly formed SSI pharma association, SME Pharma Industries Confederation (SPIC) has sought immediate intervention of Prime Minister Dr Manmohan Singh and Congress president Sonia Gandhi in the fixed dose combination issue which has hit the SSI badly.
In a letter addressed to the Prime Minister, the SPIC said that the FDCs should not be withdrawn unless adverse data is available with the DCGI. The association pleaded that some of the FDCs listed by the DCGI has been in the market for the last more than one decade. The association has sent copy of the letter to Congress president Sonia Gandhi, Chemicals Minister Ramvilas Paswan and senior officials of the central government.
The letter said, "The Drug Controller General of India (DCGI) has brought out a List of 294 FDCs, some of which have been used for over 10-15 years. The State Licensing Authorities, who permitted these drugs without taking NOC from DCGI, have been asked to withdraw the permissions to manufacture them with immediate effect because they were not approved by the DCGI as per Drugs Act".
"In a meeting with the industry in NIPER on 27 October 2007, in consumer interest SSI agreed to stop manufacturing Drugs for which adverse data was generated by the DCGI but raised serious objections on withdrawal of permission on drugs for which no adverse data is available with the DCGI. While SSI has generated demand for them, obviously, these drugs shall be handed over to large industry on a platter since they are the only ones to afford the cost of generating data required for approval from DCGI office", the letter dated October 30 said.
The DCGI order of withdrawing licenses issued to 294 FDCs will hit the SSIs badly as a large number of SSIs survive on combination drugs. While big companies can approach the DCGI office in Delhi, the SSIs will find it difficult to get the licenses from Delhi as it involves an expenditure to the tune of Rs 3 lakh for each product.