Drug manufacturing licence applications and renewals, new drug approval applications before CDSCO, Schedule M GMP compliance, drug import licence applications, and the management of CDSCO inspection findings and show cause notices. GP advises pharmaceutical companies on the complete drug regulatory lifecycle — from preclinical submissions through manufacturing compliance to post-market surveillance obligations.
Pharmaceutical patent prosecution and litigation — pre-grant and post-grant patent oppositions before the Indian Patent Office, Section 3(d) challenges to pharmaceutical patent applications, compulsory licensing proceedings, and patent infringement proceedings in the High Courts. GP navigates India's unique patent framework for both originator and generic pharmaceutical companies.
Clinical establishment licensing, NABH accreditation compliance, National Medical Commission and state medical council proceedings against hospitals and doctors, consumer forum proceedings in medical negligence cases, and the employment law framework for healthcare professionals. GP advises hospital groups on the complete regulatory compliance framework.
Challenging or complying with drug price controls under the DPCO 2013, NPPA proceedings on overpricing, and the negotiation of pricing for drugs brought under scheduled formulations. GP advises pharmaceutical companies on DPCO compliance, represents companies in NPPA proceedings, and handles High Court challenges to NPPA price fixation orders.
Clinical trial regulatory compliance under the New Drugs and Clinical Trials Rules 2019, Institutional Ethics Committee constitution, subject safety monitoring, adverse event reporting to CDSCO, and the management of CDSCO inspections of clinical trial sites. GP advises sponsors, CROs, and clinical sites on the legal framework for clinical research in India.
Mergers and acquisitions in healthcare and pharmaceutical — hospital group acquisitions, pharma company mergers, diagnostic chain roll-ups, and private equity investment in healthcare. Healthcare M&A requires specialist due diligence on drug licences, CDSCO approvals, clinical trial compliance, medical council registrations, and CCI merger notification.
Represented a leading Indian generic pharmaceutical company in a pre-grant opposition to an originator's patent application for a new crystalline form of an established anti-hypertensive molecule. GP established that the new crystalline form did not demonstrate significantly enhanced therapeutic efficacy — as required by Section 3(d) — and that the only advantage was improved stability, a manufacturing benefit not a patient benefit. The Patent Office rejected the patent application, clearing the generic company's planned launch.
Challenged an NPPA overpricing demand of Rs.22 crore for a cardiovascular drug. GP filed a writ petition in the Delhi High Court establishing that the NPPA had applied the wrong price computation methodology. The Delhi High Court set aside the overpricing demand and directed the NPPA to recompute the ceiling price using the correct methodology — which produced a ceiling price above the company's selling price, eliminating the overcharging allegation.
Managed the CCI merger notification for a hospital group acquiring the only other multi-specialty hospital in a Tier 2 city. GP filed the mandatory notification, presented the market analysis to the CCI with a geographic market definition based on patient travel patterns, and negotiated the behavioural conditions the CCI imposed — price caps on the most common procedures for three years. The merger was cleared with conditions.
The healthcare & pharma practice team operates across Mumbai, Delhi, Bangalore, and Chennai, with specialist capabilities in each of the practice areas listed above. Contact GP to discuss how we can assist your organisation.
GP advises healthcare & pharma clients across the complete spectrum of legal and regulatory needs. Tell us about your matter and we will put you in contact with the right team.