Amid the geopolitical turmoil of the US-IsraelIran tussle, the loss of patent exclusivity of semaglutide on March 20 marked the start of another conflict: a price war as companies scrambled to claim a fatter slice of the GLP-1 market.
The flood of generic GLP-1s launched post March 20 will probably be part of many business school case studies, analysing launch strategies and branding gambits. Most of the big names launched within a few days but it is estimated that there could be as many as 40-50 generic semaglutide brands within a few months.
But not all brands will survive the GLP-1 gold rush. Firstly, the regulatory scrutiny has increased many fold, even before the launch of generic GLP-1s. On March 10, the regulator CDSCO issued a strict advisory to all manufacturers, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage. Significantly, the Advertising Standards Council of India (ASCI) was also copied on this advisory, perhaps hinting that consumers could route their complaints through this channel as well.
Clearly, the regulator would like to drive home the message that these are not “weight loss shots”, as they have been dubbed on social media reels, but medicines, and like all medicines, come with side effects.
Central and state regulators have also scaled up enforcement activities. Within four days of patent loss, 49 entities were audited and inspected, including online pharmacy warehouses, drug wholesalers, retailers, wellness and slimming clinics. The fact that these inspections were followed by notices served to defaulting entities proves that the Drugs Controller of India /CDSCO will remain vigilant.
A PIB press note dated March 24 release stressed the consequences of the misuse of weight loss drugs without clinical oversight, advising citizens to use such medications only under the guidance of qualified medical practitioners. The release also reiterates that these drugs have been approved in India under specific conditions, and can only be prescribed by endocrinologists and internal medicine specialists and for some indications by cardiologists. Regulatory surveillance will intensify in the coming weeks and the release warns that “non-compliances will be dealt with strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws.”
Secondly, while the regulatory spotlight will hopefully discourage smaller companies hoping to make a quick buck off the semaglutide wave, the real battle will be to make patients overcome needle phobia, and stick to the routine. Even though prices have reduced, a regimen of generic semaglutide is still an expensive prospect.
Savvy pharma companies are already looking beyond semaglutide, to other molecules set to slide off the patent cliff from 2026-2032. Our cover story in the April edition of Express Pharma, titled, ‘Patent expiries ahead: Is India Pharma Inc ready?’, gets experts to break down the opportunity, the risks and the challenges as companies strategise for the next opportunity.
Another story in the April edition, titled, ‘Safeguarding the pharma excipients supply chain’, analyses a seemingly small but significant policy amendment. From March 1, Quick Response (QR) Codes or barcodes on the labels of the top 300 medicine brands in India will have to include “qualitative details” of excipients used during the making of these products.
Adding excipient data to dynamic QR codes will not entail additional costs for pharma companies already complying with the QR Code Rule. The challenges lie at the excipient supplier’s end, as it triggers a move to more transparent systems and standardised excipient nomenclature. These systems need a level of digital readiness which might not be possible for smaller excipient makers. While the industry is ready to comply, they feel a phased roll out would result in better adoption.
Including details of excipients in QR codes has been on the cards for a few years, especially after repeated incidents of deaths linked to cough syrups containing non-medical grade diethylene glycol (DEG) and ethylene glycol (EG). The QR code amendment. if implemented in letter and spirit, is one step towards helping India Pharma Inc rebuild lost trust.
Pharma companies are also tracking another harsh reality check: the US-Israel-Iran situation. Namit Joshi, Chairman of Pharmexcil estimates that a complete disruption of March’s exports to the GCC markets could result in a potential loss of approximately Rs 2,500 to Rs 5,000 crores for the Indian pharma industry. He also flags the escalation of costs throughout the pharma supply chain, driven by crude oil price fluctuations, rising logistics costs for APIs and finished formulations and shipping delays that will affect inventory cycles.
There are already reports that certain medicines like vitamins and antibiotics could get more expensive to manufacture as input prices increase.However since these are price controlled, cost increases will have to be absorbed by manufacturers. Once again, smaller companies will feel the pinch more and faster than their larger counterparts.
As pharma companies deal with price wars, increasing regulatory heat and a volatile geopolitical situation, navigating this perfect storm needs patience and resilience. And perhaps the same regulator-industry cooperation seen during COVID times.
VIVEKA ROYCHOWDHURY, Editor
viveka.r@expressindia.com
viveka.roy3@gmail.com