Pharma Industry Seeks Clear Guidelines on CDSCO Solvent Export Rules

The pharmaceutical sector is calling for precise guidance regarding the Central Drugs Standard Control Organisation's (CDSCO) recent mandate that demands batch-wise digital clearance for certain high-risk pharmaceutical solvents. This request comes as exporters worry about potential disruptions in their supply chains caused by the new regulations.

Under the new directive, state and Union Territory drug regulators must ensure that all manufacturers and suppliers of designated pharma-grade solvents register on the Online National Drugs Licensing System (ONDLS). Additionally, they are required to secure a no-objection certificate (NOC) before distributing each batch of these solvents.

Industry leaders emphasize that the current order lacks clear distinction between solvents destined for domestic markets and those meant for export. It appears the rule covers the entire supply chain, including manufacturers producing formulations for international markets, which has caused uncertainty among exporters.

A Delhi-based pharmaceutical executive highlighted the need for regulatory clarification, stating, "A regulatory clarification would help avoid differing interpretations across states, as cough syrups need a Certificate of Analysis from an approved government laboratory before export." The CDSCO had not provided responses to related inquiries at the time of this report.

Rishi Agrawal, co-founder and CEO of TeamLease Regtech, explained that export-oriented units operate under drug manufacturing licenses governed by the Drugs and Cosmetics Act and rely on the same solvent supply chains as domestic producers. He noted, "Ideally, a medicine made for an Indian patient should meet the same standard as one made for export. The new solvent tracking system supports this because it works at the input level." This approach aims to enhance traceability of critical raw materials used in pharmaceutical products.

While the industry generally supports improved traceability, concerns have surfaced regarding the ability of state drug control departments to handle the potentially large number of batch-wise clearance applications. Many of these departments face staffing shortages, which could result in delays in issuing NOCs, hampering solvent supplies to formulation manufacturers.

Agrawal pointed out that smaller manufacturers are especially vulnerable due to their limited inventory and reliance on regional suppliers. This vulnerability might lead to supply bottlenecks, impacting production timelines. Additionally, rural distribution may face short-term challenges as a consequence of the new requirements.

India's cough and cold medication market is estimated to be worth around ₹7,000 crore. Rural regions such as Uttar Pradesh, Madhya Pradesh, Maharashtra's Vidarbha area, and Rajasthan are among the highest consumers of cold medicines, particularly syrups. These markets are highly price sensitive and depend heavily on inputs from small and regional manufacturers.

The same Delhi-based executive elaborated, "Rural markets are highly price sensitive and heavily lean on inputs manufactured by small and regional manufacturers." These smaller companies typically procure solvents through local suppliers and traders and may not have the infrastructure to comply quickly with digital registrations and batch-wise approvals. Delays in obtaining NOCs could disproportionately affect these manufacturers.

In contrast, larger companies maintain greater stock levels and have more extensive supplier networks, allowing them to better absorb any regulatory delays. Agrawal noted, "A gap at their end would show up first on pharmacy shelves in small towns and villages."

Arushi Jain, director at contract drug manufacturing firm Akums Drugs, stressed the importance of well-defined timelines and cooperation among regulators, suppliers, and manufacturers. She said these elements are crucial to ensure that enhanced quality controls do not disrupt medicine availability.

The CDSCO’s directive arrives in a context of increased regulatory scrutiny following a tragic incident in 2025 when 24 children died in Madhya Pradesh after consuming Coldrif cough syrup contaminated with diethylene glycol (DEG). DEG is a toxic industrial chemical sometimes illegally used as a substitute for propylene glycol, a solvent critical in dissolving drugs into liquid form for syrups.

The solvents now subject to batch-wise tracking include glycerin, propylene glycol, sorbitol, maltitol, polyethylene glycols, polysorbates, and ethyl alcohol. These substances are commonly used in various pharmaceutical dosage forms such as oral liquids, tablets, capsules, ointments, and injectables.

Overall, the pharmaceutical industry’s push for clarity reflects the balancing act between maintaining drug quality and ensuring uninterrupted supply, particularly for export markets and vulnerable rural areas.