While India’s CDMOs are well positioned to capitalise on the booming GLP-1 market, the recurring episodes of contaminated cough syrups are warning flags. Loss of semaglutide’s key patent in March 2026 will see generics enter the market, putting further pressure on the price. And as manufacturers fight to conserve margins, cutting corners might result in sub-optimal quality.
Our cover story in the November edition, titled, Needles, Pens and Pressure: The GLP-1 challenge, highlights how companies are gearing up for this opportunity. The challenge of meeting the increased demand for prefilled pens and injectors will call for deeper pharma–device collaborations, analytical innovation, and sustainable design
Interestingly, an IQVIA report, titled ‘Off-patent semaglutide in 2026: the next revolution in anti-obesity medications’, points out that of the over 10 companies filed for Subject Expert Committee (SEC) submissions in India to conduct Phase III studies for semaglutide, seven of them focus on oral versions.
This seems like a differentiation strategy, also anticipating the cold chain challenges of injectable GLP1s in India. Oral doses would also address needle-phobia issues.
The IQVIA report points out that Indian companies have begun laying the groundwork for international expansion, referencing Biocon partnering with Biomm who will file and commercialise their off-patent candidate in Brazil.
More recently, Eli Lilly (Lilly), and Cipla announced an agreement to distribute and promote tirzepatide in India under a second brand name, Yurpeak, at the same price as its Mounjaro.
However, the recent incident of cough syrup contamination with diethylene glycol (DEG), which led to the deaths of children in India, resurrects questions and doubts about our commitment to quality and regulatory compliance.
Such lapses undermine India’s credibility in global markets and could sour the promise of opportunities like the GLP-1 boom. Following similar incidents in overseas markets in 2022–23, the Central Drugs Standard Control Organisation (CDSCO) had mandated pre-export testing of cough syrups.
And now the same norms are being applied to the domestic market. On October 22, CDSCO mandated a Digital Monitoring System on the Online National Drugs Licensing System (ONDLS) portal for monitoring the supply chain of high risk solvents.
This followed a directive dated October 07, which requested all the States/UTs to take measures to ensure testing before the manufacture and release of cough syrups batches to the market by monitoring during inspections, sensitising the manufacturers through circulars, etc.
On October 27, the CDSCO released details of the number of batches of cough syrup samples received for testing in Central/State drug testing laboratories. With Health Minister JP Nadda himself asking officials to “end it once and for all,” could cough syrup manufacturers finally take this issue seriously?
As December 31, the compliance deadline for Revised Schedule M draws near, it’s anyone’s guess on how many small and medium manufacturers with a turnover of Rs 250 crore or less, will be ready for the new norms. The industry might lobby for an extension of this deadline but this might be counterproductive, sending the wrong signals.
Many reports highlight the potential of the CDMO opportunity for India but of late, these reports come with caveats. A recent Biobeat report forecasts that CDMOs in China and the US will experience the fastest growth, with mAbs, PROTACs, ADCs and sterile filling expected to drive demand in 2026. In terms of geographic locales, China and the US look best placed to capitalise in the medium term, with India cooling its growth from last year, and Europe remaining more neutral in outlook.
In development, CDMOs in the US, EU, and India are expected to see rising demand from Western innovators. However, Western CDMOs may face increasing pricing pressure from drug pricing reforms, while Indian CDMOs are likely to retain stronger pricing leverage and remain well positioned.
Looking ahead, as per the report, while a few very large CDMOs have benefited from significant GLP-1 revenues, oncology appears to offer greater growth potential for mid- and small-scale CDMO providers. Overall, for CDMOs focused on clinical activities, demand remains stable, with the report forecasting a return to higher growth over the next year.
But it won’t take long for the GLP-1 boom to go bust, with many countries competing for the same opportunity. India’s MSME pharma manufacturers need to see the short term pain of upgrading to the revised Schedule M as an investment for the future. Without this, they will not figure in future pharma supply chains. Unfortunately, it only takes a few deviant cough syrup makers to change the narrative.
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com