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MSMEs concerned over negative impact on trade in around 55 semi-regulated & non-regulated overseas markets
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Shardul Nautiyal, Mumbai
February 23 , 2026
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Even as MSMEs are struggling to comply with Revised Schedule M, pharma exporters have highlighted the concern of negative impact on trade in around 55 semi-regulated and non-regulated overseas markets served by pharma MSMEs.
Besides this, it has also been learnt that countries in certain overseas markets does not have a fully independent or a dedicated national drug regulatory authority like those in regulated markets. These overseas markets include Andorra, Antigua & Barbuda, Belize, Cabo Verde, Central African Republic, Comoros, Djibouti, Dominica and Equatorial Guinea, to name only a few.
Exporters have highlighted that Government’s regulatory policies like Stringent Regulatory Authority (SRA) approval to get export No Objection Certificates (NOCs) for semi-regulated and non-regulated markets and mandate of exclusive online submission of Certificate of Pharmaceutical Product (CoPP) applications have also been delaying exports and can hamper export growth.
Exporters have also sought favourable domestic government policies to find alternative markets outside regulated markets like the US, considering the US policies of imposing penalty and tariffs in the long term. The US is India's largest overseas pharma market, with exports rising 21 per cent from USD 8.1 billion in FY24 to USD 9.8 billion in FY25.
Exporters have also highlighted critical areas of delay in export consignments of various kinds of medicines at ports. Documentation which is beyond the jurisdiction of the port authorities are demanded such as manufacturing license with text "for export only", Certificates of Analysis (CoA) and WHO-GMP certificates for product that are freely consumed by patients in India but access curtailed to Indian origin and other nations patients outside India. It has been observed that goods marked as Indian Pharmacopoeia (IP) are being stopped by the port authority under the pretext that these are meant for domestic sales only.
The revised Schedule M aligns India's manufacturing standards with global norms, such as those from the World Health Organisation (WHO), to ensure the quality and safety of pharmaceutical products.
Exporters are also looking for registration to new sites or re-register new products in the existing sites to keep their supply chains active in the export markets. The need for such diversification is that many domestic manufacturing units may face closure for non-compliance to revised Schedule M deadline.
The deadline for pharma MSMEs to comply with the revised Schedule M (good manufacturing practices) was December 31, 2025. This extension was granted by the Union ministry of health, with the condition that small and medium manufacturers applied for the extension with an upgrade plan by May 11, 2025, to the Central Drugs Standard Control Organisation (CDSCO).
Key provisions of revised Schedule M guidelines include modernized facilities to prevent contamination and improve cleanliness, validated equipment towards stringent maintenance of production equipment, environmental controls towards adherence to global standards for air, water, and waste management, Pharmaceutical Quality Systems (PQS): robust systems to guarantee consistent quality, Product Quality Reviews (PQR), which are regular evaluations to ensure ongoing compliance.
According to experts, there are challenges to comply with revised Schedule M guidelines, especially for MSMEs, which have limited resources. Many require financial assistance and technical support to upgrade their operations.
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