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Nandita Vijayasimha, Bengaluru November 07 , 2025
The Indian API (active pharmaceutical ingredient) companies are now facing the major challenge of continued dumping of APIs by China at unreasonably low prices. 

It is crucial for the government to implement protective measures, such as a Minimum Import Price (MIP) or anti-dumping duties, to safeguard these strategic investments. Without such interventions, domestic manufacturers face the risk of closure, which would undermine the core objective of the PLI (production linked incentive) scheme. This should be seen as a matter of national supply security similar to rare earth materials rather than just a question of affordability, said Ritesh Shah, Jt. managing director, Anuh Pharma.

No doubt the PLI scheme played a pivotal role in rebuilding India’s API manufacturing base and reducing import dependence, particularly for critical fermented products such as penicillin-G, clavulanic acid and rifampicin, he added.

But the true measure of success for the PLI scheme should not be a reduction in API prices, but rather a meaningful reduction in import dependence. Both the government and consumers must be prepared to support a slightly higher cost in the short term to ensure long-term self-reliance and security of supply.

It is imperative that the government introduces protective measures like MIP or anti-dumping duties to safeguard these strategic investments. Without such intervention, domestic manufacturers risk closure, undermining the very objective of the PLI scheme, Shah told Pharmabiz in an email.

The current scene for production and sale in domestic market and exports for macrolides and anti-TB products, anti-bacterials, anti-malarial, and corticosteroids indicates robust growth in the wake of infections and rise in communicable diseases.

In the macrolide range azithromycin is still the most widely used API. The local demand varies between 1,000 to 1,500 ton which is stable since the last few years. The price of the API is up by 10% YoY basis due to the Chinese monopoly in starting material erythromycin thiocyanate.

When it comes to anti TB drugs, the first line therapy of rifampicin, ethambutol, pyrazinamide and Isoniazid still prevails. The demand for API depends on government tender as this is normally offered free of cost. With the government focus to eradicate TB cases being a priority, here Anuh Pharma is among the largest manufacturers of pyrazinamide. Under anti malarials, sulfadoxine, pyrimethamine and amodiquine are manufactured with maximum exports to Africa funded by global funds or USAID.

Antimicrobial resistance stems mainly from self-medication, incomplete dosage adherence, and over-prescription, for example azithromycin was extensively prescribed for Covid-19, he noted.

Even the Indian corticosteroids market is growing at 6–7%. This segment is dominated by a few large API manufacturers, among whom Anuh Pharma ranks among the top three producers of betamethasone salts. Also, the company holds a significant market share in prednisolone sodium phosphate and dexamethasone sodium phosphate. Corticosteroids replicate the action of cortisol, a vital hormone responsible for regulating inflammation, metabolism, immune response, and stress. Given the rising prevalence of lifestyle disorders, the demand for this class of products is expected to remain forward, said Shah.

Key challenges impacting bulk drug manufacturers is the  oversupply, particularly following the large-scale capacity expansions in India and China in the aftermath of the Covid-19 pandemic. API prices have declined sharply by nearly 40–50% from post-Covid highs, with several products now trading at lifetime low levels. Many manufacturers, in Gujarat and Hyderabad, are struggling with under-utilized facilities as API production becomes unviable. The only areas currently yielding sustainable margins are controlled substances and CDMO (contract development and manufacturing organisation) operations, where entry barriers remain higher, said Shah.

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