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Shardul Nautiyal, Mumbai January 05 , 2021
The National Pharmaceuticals Pricing Authority (NPPA) has granted exemption to Sun Pharmaceuticals from the provisions of DPCO, 2013 for its FDC drug  silver sulfadiazine IP (Nanonized) 0.5% w/w and chlorhexidine gluconate 0.2% w/w topical cream for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country. Further, the period of five years is co-terminus with the duration of Indian patent.
 
Now, therefore, in exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O. 1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s Sun Pharmaceuticals Industries Limited is exempted from the provisions of DPCO, 2013 under para 32 (i) of the said order in respect of above said drug viz. Fixed dose combination (FDC) of  silver sulfadiazine IP (Nanonized) 0.5% w/w and chlorhexidine gluconate 0.2% w/w w topical cream.

Earlier, the Sun Pharmaceuticals had submitted an application for exemption of this drug from the provisions of DPCO, 2013 under para 32 (i) which was duly approved by the Office of Central Drugs Standard Control Organisation (CDSCO) as ‘new drug’ under the Drugs and Cosmetics (D&C) Act, 1940 and Rules thereunder.

The NPPA noted that Sun Pharmaceutical Industries Ltd meets the requirement of para 32(i) of DPCO 2013 and decided that exemption may be granted to Sun Pharmaceutical Industries Ltd under para 32(i) of DPCO, 2013 for their product fixed dose combination (FDC) of silver sulfadiazine IP (Nanonized) 0.5% w/w and chlorhexidine gluconate 0.2% w/w topical cream.

Further, the patent office, India has granted patent certificate to Sun Pharmaceutical Industries Ltd for an invention entitled ‘A stable topical pharmaceutical composition comprising nanonized silver sulfadiazine’ for the term of 20 years from 27th July 2016 in accordance with the provisions of the Patents Act, 1970 (Patent No. 349599 and Date of Grant: October 20, 2020).

Now, therefore, in exercise of the powers delegated under para 32 of the DPCO- 2013 vide S.O. 1394(E) dated May 30, 2013 issued by the Government of India in the Union ministry of chemicals and fertilizers, Sun Pharmaceuticals Industries Limited is exempted from the provisions of DPCO, 2013 under para 32 (i) of the said order in respect of the said drug for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.  Further, the period of five years is co-terminus with the duration of Indian patent.

As per NPPA, the company shall inform NPPA the date of commercial marketing of FDC of silver sulfadiazine IP (Nanonized) 0.5% w/w and chlorhexidine gluconate 0.2% w/w topical cream’ in the country and the Price to Retailer (PTR) and Maximum Retail Price (MRP) fixed by the company in respect of above said formulation by issuing a price list in Form V under DPCO, 2013.

The Union ministry of chemicals and fertilizers vide S.O.1394 (E) dated May 30, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities (EC) Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 32 of the said order to be exercised by the NPPA on behalf of the Central government.

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