New Delhi, Sep 18: In a major relief for the pharma sector, the government has dismissed the mandatory rule for drug manufacturers to recall, or re-label medicines already released in the market before September 22, the Department of Pharmaceuticals said.

This follows the latest revision in Goods and Services Tax (GST) rates early this month by the GST Council, which reduced the GST on medical devices to 5 per cent from 12 per cent.

The National Pharmaceutical Pricing Authority (NPPA), in an Office Memorandum, clarified that companies can instead comply by ensuring revised pricing is reflected at the retailer level.

“All manufacturers/ marketing companies selling drugs/ formulations shall revise the Maximum Retail Price (MRP) of drugs/formulations (including medical devices). The manufacturers/ marketing companies shall issue a revised price list or supplementary price list to dealers and retailers for display to consumers, and to State Drug Controllers and the Government, reflecting the revised GST rates and revised MRP,” the NPPA said.

“Recalling, re-labelling, or re-stickering on the label of a container or pack of stocks released in the market prior to September 22, 2025, is not mandatory, if manufacturer/ marketing companies are able to ensure price compliance at the retailer level,” according to the FAQs issued by the Finance Ministry.

The pharmaceutical industry had earlier expressed concerns over the practical challenges and costs of recalling and re-labelling medicines already in circulation.

The new decision to permit revised price lists instead is expected to reduce disruptions in the supply chain, ensuring that patients do not face shortages of essential medicines due to technical labelling requirements.

Retailers will now be responsible for displaying the updated price lists, enabling consumers to access medicines at the revised rates without confusion.

Meanwhile, the Association of Indian Medical Device Industry (AiMeD) has submitted recommendations to the Union Finance Minister and GST Council Chairperson Nirmala Sitharaman, seeking balance GST reforms.

AiMeD emphasised that additional reforms are critical to address persisting challenges such as working capital stress, inverted duty structures, and restricted refund eligibility.

Key reforms proposed by AiMeD include simplification of the GST refund mechanism by extending refund eligibility to Input Tax Credit (ITC) on services and capital goods, which are currently excluded.

It also includes a uniform 5 per cent GST rate on inputs; amendment of Rule 89(5) to include ITC on services, capital goods; and automated, time-bound refunds to introduce provisional 90 per cent refunds within strict timelines to ease liquidity for manufacturers.

“Global best practices in countries like Australia, New Zealand, Canada, and the EU allow full refund or carry-forward of unused GST/VAT paid on inputs -- including services -- so that exporters and businesses with inverted duty structures do not suffer cash flow blockages or tax cascading,” said Rajiv Nath, Forum Coordinator, AiMeD.

"India must adopt similar reforms if we want to lower healthcare costs, strengthen Make in India, and improve global competitiveness," he added.

(IANS)

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