In a major move to bolster drug quality standards and maintain India’s reputation as the “pharmacy of the world”, the regulator has overhauled the drug export rules, mandating that unapproved medicines will no longer be exported unless cleared by importing nations or top global regulators. Speaking at the Global Drug Regulatory Conclave 2026, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said that the Central Drugs Standard Control Organisation (CDSCO) has tightened the export No Objection Certificate (NOC) framework.
“As a country, India has a lot of commitment, and we are together working to strengthen this most important part of the value chain – the drug regulatory system – to help further the global healthcare supply chain,” Raghuvanshi said.
SRA Mandate
Under the revised rules, products not approved in India can only be exported if the importing country has explicitly approved them. Recognising that some smaller nations lack robust regulatory authorities, CDSCO has developed an alternate pathway under which the drug must be approved either by India or by one of six stringent regulatory authorities (SRAs) in regions like the US, the UK, Canada, Europe, Australia, or Japan.
“Unless until the importing country has approved the product, we will not allow that to be exported from India. The purpose is that whatever we make and export from India should have been reviewed and approved by one major agency of the world, so that safety and efficacy is assured,” he stated.
Raghuvanshi said that the NOC ( No Objection Certificate) system is now fully digital. Over the past year, CDSCO has processed 23,000 export NOCs – averaging 2,000 per month – slashing the approval processing period to below 10 days.
The tightening has come as India has grown its exports at a fast clip. According to official data, pharma exports increased from $20.7 billion in FY20 to $30.4 billion in FY25, translating into a compounded annual growth rate (CAGR) of 8%. The country currently serves 40% of US generic demand and 20% of the world’s generic medicines. The medical device exports too have surged from $2.5 billion in FY20 to $4.1 billion in FY25 due to the rapid expansion of domestic manufacturing, regulatory reforms that have strengthened quality standards and export processes.
Risk-Based Audits
Beyond exports, Raghuvanshi outlined a broader regulatory overhaul centred on digitisation, risk-based oversight and innovation. For example, the CDSCO is undergoing a full digital transformation through the Digital Drug Regulatory System (DDRS) with over 99% of regulatory processes now digitised. Further, the regulator has revamped its inspection framework, completing more than 1,200 risk-based audits over the past 3.5 years, while using analytics to identify manufacturers with repeated instances of Not of Standard Quality (NSQ) drugs. The compliance history is now being shared with government procurement agencies to help them identify reliable suppliers for public tenders.
“Today we can identify any company which is having the highest number of NSQs. This pushes the system towards quality manufacturing because if there are more NSQs and audit failures, the companies may be debarred from taking part in the tender process,” Raghuvanshi said.
To improve the access to innovative medicines, Raghuvanshi said by adopting a system that relies on international trial data, local clinical trial waivers are now granted for 25-30% of new drugs. “If a multinational company’s product is first-in-class or significantly better than the existing treatments, we are giving waivers for local clinical trials for early availability to Indian patients,” he said.