The Confederation of Indian Pharmaceutical Industry (CIPI), an association of small scale pharma units in the country, has urged the Department of Pharmaceuticals (DoP) to exempt SSIs from several provisions of DPCO, 2013 on the lines of exemptions granted to them from the provisions of paragraph 8 of the Drugs (Price Control) Order, (DPCO) 1995.

In a letter written to DoP secretary, CIPI said that the Ministry of Chemicals & Fertilizers in its order no. 5.0.134 (E) dated March 2, 1995 had exempted small scale manufacturers from the provisions of paragraph 8 of the Drugs (Price Control) Order, 1995 which specifies that the maximum retail price of scheduled formulations shall be fixed by the manufacturers on the basis of ceiling price notified by the government plus local taxes wherever applicable.

But in the DPCO, 2013 no such relief has been given to small scale manufacturers.

In the letter, CIPI appealed to the DoP to exempt SSIs from registration under IPDMS and accept various Forms prescribed under DPCP, 2013 from them in soft copies followed by hard copies.

Small scale manufacturers should be exempted from filing of Form - 1 (para 15) if they follow the retail price fixed by NPPA for a new drug formulation for any other manufacturer and the price list in Form V of the said formulation is filed, said executive secretary of CIPI Sudesh Kumar.

Small scale manufacturers should be exempted from the provisions of paragraph 13(2) of DPCO, 2013 and should be given an option to fix ceiling prices of their scheduled formulations at the level of ceiling prices of the said formulation as notified by NPPA, if the formulation is being sold at a price below the ceiling prices as notified by NPPA. This will be in consonance with the provisions of Paragraph 4(v) of the NPPP, 2012, he said.

He further added that small scale manufacturers should also be exempted from seeking permission from NPPA under paragraph 21(2) of DPCO, 2013 for discontinuation of the production of a scheduled formulation if the market share of the manufacturer is insignificant which may be fixed after due deliberations with the stake holders.

The letter was written to secretary, DoP after a meeting held by CIPI in September at Delhi to deliberate provisions of DPCO 2013 affecting interests of small scale pharmaceutical manufacturers.