Drugs (Prices Control) Amendment Order, 2019

Jan 07, 2019 | by Avantis RegTech Legal Research Team


The Department of Pharmaceuticals on January 03, 2019 has published Drugs (Prices Control) Amendment Order, 2019 to further amend the Drugs (Prices Control) Order, 2013

The following amendments in the Drugs (Prices Control) Order, 2013 are as under:

In Paragraph-9 which specifies Reference data and source of market based data:

A.      for sub-paragraph (1), the following sub-paragraph shall be substituted, namely:

“(1) The source of market based data shall be the data available with the pharmaceutical market data specializing company as decided by the Government and if the Government deems it necessary, it may validate such data by appropriate survey or evaluation.”;

B.      after sub-paragraph (6), the following sub-paragraph shall be inserted, namely:

“(7) Notwithstanding anything contained in this paragraph, for fixing or revising the ceiling price for formulations, the Government may, if it is necessary so to do, consider market based data available for any month, as deemed fit.”

C.      (A)in Paragraph-32, for sub-paragraph (i), the following sub-paragraph shall be substituted, namely:

“(i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970), for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.”;

D.      after sub-paragraph (iii), the following sub-paragraph shall be inserted, namely:

“(iv) Drugs for treating orphan diseases as decided by the Ministry of Health and Family Welfare, Government of India.”

[Order No. S.O. 39(E)]

URL: http://egazette.nic.in/WriteReadData/2019/194703.pdf


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