Government of India
Ministry of Chemicals & Fertilizers
National Pharmaceutical Pricing Authority

New Delhi, the 19th August, 1999

PRESS NOTE
“For the attention of Small Scale Pharmaceutical manufacturers”

The Govt. of India in the Ministry of Chemicals & Fertilizers, Deptt. of Chemicals & Petrochemicals issued a notification vide S.O. 134(E) dated 2nd March, 1995 providing for exemption of drug manufacturing units registered as small scale industry unit in respect of price fixation for non-ceiling packs of scheduled formulations under Drugs (Prices Control) Order, 1995 subject to fulfillment/compliance of certain conditions stipulated there in.

The National Pharmaceutical Pricing Authority (NPPA) which has been interalia, delegated with the responsibility to fix/revise the prices of drugs under DPCO, 1995 has observed that SSI units which do not qualify for exemption under the above Govt. S.O. are manufacturing and selling drugs on the assumption that their status as SSI per se accords exemption to their products. It is brought to the notice of all the concerned that the exemption provided in the above order is not automatic and evey unit requires to fulfil the following conditions before availing the exemption :

1. “It is an independent unit/company and not a subsidiary of or owned or controlled in any manner by any other undertaking which is not so exempted from the provisions of the Drugs (Prices Control) Order, 1995;
2. the formulations are marketed by the concerned unit/company in their own brand names and trade marks or in the brand or trade name of any other small scale industry unit;
3. a declaration complying with conditions (i) and (ii) above along with a copy of Rgistration Certificate as a small scale industry unit is submitted to the Government within sixty days from the date of this notification in case of existing units and sixty days from the date of commencement of production in case of new units.”

Further, as clarified in the note no. (ii) of the order “the exemption is granted only to those products, manufactured in their own factory under their own Registration Certificate or in the factory of any other small scale industry unit. “

In view of the above those units that consider any of their product eligible for the exemption, should submit declaration to the Govt./ NPPA by furnishing information and documentary evidence required under the above Govt. S.O. The units are therefore advised to comply with the conditions of notification forth with.

Any manufacturing unit selling the drug formulations in violation of the provisions of the DPCO, 1995 shall be liable to penal action in accordance with the provisions of Essential Commodities Act under which DPCO, 1995 has been promulgated and also to pay the overcharged amounts to the Government.

For further clarifications, if any, the units may write to the Dy. Director (Monitoring), National Pharmaceutical Pricing Authority, Department of Chemicals & Petrochemicals, Ministry of Chemicals & Fertilizers, 19th Floor, Jawahar Vyapar Bhawan, Janpath, Tolstoy Marg, New Delhi-110 001 P : 3701138.