Regulatory & Compliance

Regulatory & Compliance

Pharmaceuticals Regulatory Works

  • First Law Firm in India to challenge the constitutional validity of the provisions of the Drugs (Price Control) Order, (DPCO) 2013. The firm represented 15 pharmaceutical companies before the Delhi High Court
  • Filed more than 35 writ petitions before the Delhi High Court challenging the ban notifications issued by the central Government, banning 344 Fixed Dose Combinations by exercising its powers under Section 26 A of the Drugs & Cosmetics Act, 1940. The matters are currently pending before the Supreme Court of India
  • Actively deals with cases challenging the price ceiling notifications/ Price Fixation of Scheduled Drugs/Office Memorandums as notified by the National Pharmaceutical Pricing Authority
  • Actively deals with cases, before High Courts & the Supreme Court pertaining to interpretation of provisions of the Drugs & Cosmetics Act, 1940, including but not related to Interpretation of export provisions of the Act
  • The Firm advices clients on the representations to be made to governmental regulatory bodies like the National Pharmaceutical Pricing Authority
  • The Firm regularly attends hearing before forums like Ministry of Chemicals & Fertilizers, Department of Pharmaceutics for and on behalf of our clients
  • The Firm regularly attends hearing before forums like Ministry of Chemicals & Fertilizers, Department of Pharmaceutics for and on behalf of our clients
  • The Firm is facilitating import of cosmetics into the country by a US based company and the mandate includes assisting the company in obtaining import licenses

Leading Pharmaceutical Regulatory Cases:

  • Cipla & Anr. v. UOI & Ors. WP (C) No. regarding the challenge to the constitutional validity of certain provisions of the DPCO,2013
  • Macleod’s v. DCGI & Anr. WP No. 2231/2016 Common Judgment dated December 01,2016 disposing off 454 petitions filed against the 344 notifications dated 10th March,2016 of the Government of India