The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities.
The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from patent filings to marketing practices. Here are four areas critical areas to watch:
1. Patent (Amendment) Rules 2024: Beware shorter timeframes
The recent amendments to the Patent Rules introduce stricter timelines for filing ‘Requests for Examination.’ Applicants now have 31 months instead of the previous 48 months from the application filing date to submit requests. This necessitates a more efficient approach to managing patent applications. Additionally, the process for considering foreign applications has been streamlined. The Patent Controller can now use information from existing databases instead of requiring applicants to submit it anew, though there are still exceptions where fresh information may be demanded. Companies must stay vigilant about these timelines and procedural requirements to avoid lapses that risk the loss of their patent rights.
2. Establishment of the R&D Indian Council ICPMRD to foster innovation and collaboration
Under the new National R&D Policy, the Indian Council of Pharmaceuticals and Med-tech Research and Development (ICPMRD) has been established to facilitate research-related collaboration among institutes, academia and the industry. ICPMRD’s establishment would enhance innovation and streamline research efforts in the pharma and MedTech sector. A dedicated portal to monitor this policy’s implementation has also been launched. Engaging with the ICPMRD can provide companies valuable opportunities for collaborative R&D, potentially accelerating the pace of innovation and improving their position in the market. It enables such companies to incorporate innovations emerging from academia and research centers, and would be a highly beneficial platform for pharma companies to engage with the Government on various schemes introduced from time to time.
3. Updates to Indian GMP rules – raising regulatory standards for drugs manufacturing
Schedule M of the Drugs and Cosmetics Rules 1945, which contains Good Manufacturing Practices (GMP) for pharmaceutical products, has been amended to include new requirements for premises, plant, and equipment. These changes mandate that only drugs can be manufactured in licensed units and introduce new quality check protocols. Companies with an annual turnover of less than INR 2.5 billion (approximately GBP 25 million) have been given a twelve-month window to comply. Adhering to these updated GMP requirements is crucial for maintaining product quality and avoiding penalties.
4. New Code for Compliant Marketing Practices tightens rules on gifts to HCPs
The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) has been introduced by the Ministry of Chemicals and Fertilizers as a code for marketing by pharma companies. It prohibits these companies from providing gifts or other pecuniary advantages to healthcare professionals. Additionally, it mandates the constitution of an Ethics Committees within manufacturing associations to address breaches of the code. Managing Directors and CEOs are to be held personally accountable for their companies’ non-adherence with these practices. If the Ethics Committee finds a company in breach of the UCPMP, it may be expelled from the manufacturing association altogether. Adopting and strictly following the UCPMP – apart from ensuring compliance – also enhances the ethical standards and safeguards the reputation of pharma companies.
These four regulatory changes are poised to reshape the industry’s landscape across India. Companies must stay abreast of these developments and proactively adjust their strategies to navigate the evolving regulatory environment. By filing requests with the Patent Controller within the new timeframes, engaging with the ICPMRD, adhering to updated GMP standards and following the UCPMP, pharma firms can effectively manage risks and leverage opportunities for growth and innovation.
For further information please contact Julia Gillert of our London office, or Atul Pandey and Arjun Bhagi at Khaitan & Co, New Delhi.
