The Centre has proposed two amendments to the Drugs Rules, 1945, aimed at easing the import of medicines and reducing regulatory hurdles for pharmaceutical research, as part of its broader push to improve ease of doing business in the sector.
The Union Ministry of Health and Family Welfare on Friday issued draft notifications proposing to relax residual shelf-life requirements for imported drugs, and introduce an acknowledgement-based mechanism for importing small quantities of drugs for examination, testing, and analysis. Both proposals have been placed in the public domain for stakeholder consultation.
Under the first proposal, the ministry plans to amend Rule 31 of the Drugs Rules, 1945, by replacing the existing requirement that imported drugs must have more than 60 per cent of their approved shelf life remaining at the time of import with a minimum residual shelf life of 12 months.
However, the existing norm of more than 60 per cent residual shelf life will continue to apply to biological products and radiopharmaceuticals because of their specialised nature and public health considerations.
The ministry said the change is expected to improve pharmaceutical supply-chain efficiency, reduce wastage arising from restrictive shelf-life requirements, and optimise inventory management while ensuring that imported medicines continue to have adequate usable shelf life before expiry.
It clarified that the proposal only changes the residual shelf-life requirement at the time of import, and does not affect regulatory standards relating to the quality, safety or efficacy of medicines.
Industry executives told Business Standard that moving from a percentage-based calculation to a fixed time threshold will have a compounding effect across the supply chain.
“When compliance becomes more predictable, importers can plan better, warehousing becomes more efficient and fewer medicines are discarded simply because a procedural formula made them harder to bring in, not because they were unfit for use,” said Rishi Agrawal, chief executive officer (CEO) and cofounder at Teamlease Regtech.
In a separate draft amendment, the ministry has proposed replacing the licensing requirement for importing small quantities of drugs meant for analytical and non-clinical testing with an acknowledgement-based system.
Currently, applicants are only able to import drugs for clinical testing provided that they have an official test licence, or Form 11.
Under the proposed framework, applicants would be required to submit a prior intimation online and would be allowed to import the drugs once an acknowledgement is generated.
“Replacing a licensing requirement with a digital intimation and acknowledgement system for low-risk imports is a meaningful reduction in procedural friction,” said an executive from a Delhi-based pharma company.
Agrawal added that when researchers, start-ups and manufacturers can begin analytical work faster, it directly accelerates the pace of innovation and product development.
The simplified procedure would apply to imports for examination, testing and analysis, except for sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances, which will continue to require prior licences.
“High-risk categories continue under stricter obligations, which is consistent with a broader direction we are seeing in pharmaceutical regulation of leveraging technology to make compliance faster and more predictable, while keeping the underlying standards intact,” Agrawal added.
The ministry said the proposal builds on a similar notification-based mechanism introduced under the New Drugs and Clinical Trials Rules, 2019, earlier this year for domestic test licences.
Extending the framework to imports is expected to reduce compliance requirements for companies, contract research organisations, biotechnology firms and research laboratories importing small quantities of drugs for R&D (research and development) purposes.
The ministry has invited objections and suggestions from stakeholders on both the draft notifications within a period of 30 days before finalising the amendments.
