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Mint
3 days ago
- Business
- Mint
Ghost prescriptions, dark stores: Why quick delivery of medicine has become a headache
Quick-commerce medicine delivery is heating up, with Zepto recently joining Blinkit and Swiggy Instamart in the race. But as the space gets crowded, concerns are mounting over prescription-only medicines without proper checks. Industry body All India Organisation of Chemists and Druggists (AIOCD) has called for regulatory scrutiny and tighter oversight. 'Medicines are not groceries that should be delivered within 10 minutes. These are highly regulated and need utmost care while handling — something that can't always be assured in a dark-store model," said Rajiv Singhal, General Secretary, AIOCD. On 13 August, the association wrote to the home affairs ministry stating that easy access through online quick-commerce delivery has led to a sharp rise in misuse, including of Schedule H drugs such as Pregabalin, used for neuropathic pain, epilepsy, and anxiety. It alleged that medicines are being issued online without genuine prescription verification, raising concerns about 'ghost prescriptions" — fake or fabricated prescriptions used to procure restricted drugs. The same day, Zepto announced its entry into pharma, offering medicine delivery within 10 minutes across metropolitan cities, according to its press release. Prior to this, Swiggy had entered the segment in August 2024, launching its 'Instamart' grocery service—which included medicines in select markets—through a partnership with PharmEasy that operated as a shop-in-shop inside dark stores in Bengaluru. Blinkit last month introduced 10-minute delivery across its dark-store network and later piloted prescription-medicine delivery (including antibiotics, eye drops, antihistamines, and skin treatments) in Bengaluru. Blinkit has entered deeper into healthcare by piloting a 10-minute ambulance service in Gurugram. Queries sent to all three companies on 13 August did not elicit a response until press time. 'If platforms commit to only e-prescriptions issued and signed by registered doctors, run an automatic check against the National Medical Register, and keep a pharmacist in the loop before dispatch, leakage can be driven close to zero—even with fast delivery," said Nilaya Varma, co-founder at Primus Partners, a management consultancy firm in Delhi. Prescription verification still murky Prescription verification for Schedule H/H1/X drugs on quick-commerce is a legal mandate, not a best-efforts standard, said Aditya Patni, Partner at Khaitan & Co. Schedule H includes prescription-only drugs like antibiotics and anti-epileptics, dispensed by pharmacists without mandatory record-keeping. Schedule H1 adds stricter control—requiring prescriptions and three years of records for abuse-prone drugs. Schedule X is the most stringent, mandating duplicate prescriptions ((two copies of the doctor's prescription), special licences, and secure storage for narcotics and psychotropics. India still lacks a clear e-pharmacy rulebook; the draft regulations were never finalised. Platforms operate under older statutes like the Drugs & Cosmetics Act, 1940 and the Pharmacy Act, 1948, which never envisaged online prescription verification or instant delivery. Draft e-pharmacy rules, 2018—requiring licensed premises, pharmacist verification, and prescription uploads—remain unnotified. "This has left a regulatory vacuum, with enforcement fragmented among state drug inspectors," said Rishabh Gandhi, founder, Rishabh Gandhi and Advocate. Many platforms leverage the 'marketplace' model — which merely connects registered pharmacies to customers — to distance themselves from liability, even while facilitating the sale of prescription-only medicines, said Patni. 'Since they act as 'intermediaries' or 'aggregators' under the Information Technology Act, 2000, they do not require a licence for sale of drugs as the actual dispensation happens through physical pharmacies which are already registered," he said, adding that quick-commerce models — which rely on dark stores — may blur this line, leading to unlicensed storage and distribution. Moreover, 'JPEG prescriptions'—photos of paper scripts—are easy to forge, reuse, or edit, said Varma. 'The last mile is often not a licensed premise with a pharmacist on record, even though the Drugs & Cosmetics Rules mandate pharmacist supervision for retail supply. In addition, catalogue mis-tags (H/H1/X drugs flagged as regular SKUs) can let restricted medicines slip past controls," he added. Regulatory concerns circle established players too. Patni notes that in February 2023, the Central Drugs Standard Control Organisation (CDSCO) issued show-cause notices to 20 e-pharmacies—including Tata 1mg, Amazon, Flipkart, and Netmeds—for allegedly selling drugs without valid licenses or prescriptions. These entities claimed intermediary status. The Delhi high court had imposed an interim ban on unlicensed e-pharmacy operations in December 2018, and in March 2024 specifically directed the health ministry to finalise a policy on online sale of drugs. Licensed pharmacies can still sell online, but with the March 2024 deadline missed, the e-pharmacy legal framework remains unclear and enforcement patchy. Pregabalin predicament Meanwhile, Pregabalin has been a flashpoint recently—its rising misuse triggered the Drugs Technical Advisory Board (DTAB) to recommend moving it from Schedule H to H1, highlighting gaps in verification and enforcement. Pregabalin can only be sold on a doctor's prescription with record-keeping and labelling compliance. Some states such as Punjab have even tightened controls on high-dose formulations and bulk sales to curb misuse and diversion. In April 2025, the DTAB recommended reclassifying pregabalin and its formulations under Schedule H1, but the change awaits a gazette notification to take legal effect. While regulators and chemist bodies flag the broader system risk, all Schedule H, H1, and X drugs—including antibiotics, opioids, and psychotropics—can be misused if prescription verification is weak, enabling diversion and unsafe consumption. "Traditional pharmacies sometimes dispense medications without strict prescription checks, especially if they know the patient personally. A physical pharmacy isn't going anywhere, so such practices are easier to trace, but with e-pharmacies, it's much harder to monitor or track, which is why the scrutiny often feels uneven," said Dr. Chitra Raju, a general practitioner in Delhi. That said, quick commerce and e-pharmacy can improve healthcare for chronic patients and expand access, particularly for the elderly and in high-traffic urban areas, said Varma of Primus Partners. 'E-pharmacies already serve 20,000+ pincodes, and quick-commerce pharmacy networks have penetration access to 100+ cities. For an ageing India—10.5% of the population is 60+, projected to reach 20.8% by 2050—reliable refills and doorstep delivery can reduce drop-offs for long-term therapies," he added. India's e-pharmacy market has around 50 players and was valued at $0.5 billion in 2019 (~2–3% of total pharmacy sales), projected to grow to $4.5 billion by 2025 at a CAGR of 44%. Major players like PharmEasy, Tata 1mg, Netmeds, and Medlife combine medicine delivery with services such as doctor consultations and lab tests, according to India Brand Equity Foundation (IBEF) under the commerce ministry.
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Business Standard
20-07-2025
- Business
- Business Standard
CDMOs gear up for peptide boom amid rising demand for weight-loss drugs
As global demand for next-generation weight-loss and diabetes therapeutics surges, India's contract development and manufacturing organisations (CDMOs) are strategically positioning themselves to capture a bigger share of the peptide market, particularly in anticipation of key patent expiries such as that of semaglutide—a blockbuster GLP-1 receptor agonist. India is poised to play a critical role in the global manufacturing of GLP-1 drugs, driven by soaring demand for therapies like semaglutide and tirzepatide. The GLP-1 market is projected to exceed $150 billion by 2030. India's peptide CDMO market, currently estimated at around $80 million, is expected to grow at a CAGR of 14 per cent until 2030. Though the country currently accounts for just 3 per cent of the global peptide CDMO space—valued at $190 billion—the growth momentum is unmistakable, according to Nilaya Varma, Co-founder and Group CEO of Primus Partners. Top Indian players in the space include Glenmark, Cipla, Divi's Laboratories, Themis Medicare, Peptomer Therapeutics, Syngene International, and Sai Life Sciences. Semaglutide patent expiry fuels strategic activity Semaglutide, the active ingredient in drugs such as Ozempic and Wegovy, is owned and produced by Novo Nordisk and is set to go off-patent in India in March 2026. Leading pharmaceutical companies, including Dr Reddy's Laboratories, Sun Pharma, Cipla, Mankind Pharma, Natco Pharma, Lupin, and Biocon, are preparing to launch drugs in this category. These companies are investing in R&D, manufacturing capacity, and collaborations to compete in this rapidly growing market. Anthem Biosciences is experiencing a surge in inquiries for peptide active pharmaceutical ingredients (APIs), including those related to weight loss. 'Semaglutide can be produced through total synthesis or biosynthetic routes. Very few companies in India can manage biosynthetic production—and we are one of them,' said Ganesh Sambasivam, Promoter and Chief Scientific Officer at Anthem. While he declined to confirm whether semaglutide is in active production at Anthem, he hinted that it may be among the peptides currently in development. Syngene highlights technical edge in peptide trials Jayashree Aiyar, Chief Scientific Officer at Syngene International, sees opportunities not just in manufacturing, but also in preclinical and clinical development. 'We've already supported preclinical studies on semaglutide and recently helped a global pharma company with a bioequivalence study using pre-filled pens,' Aiyar said. These studies included developing and validating sensitive LC-MS/MS methods to measure semaglutide plasma levels—a significant technical challenge for peptides. Syngene's case study on semaglutide demonstrates the rigorous planning and execution required for clinical bioequivalence trials involving peptides. With gastrointestinal side effects common among test subjects, the company had to implement robust risk management and continuous patient support mechanisms. On the analytical front, it overcame complex challenges like autosampler carryover and low detection limits through custom-developed chromatography and mass spectrometry protocols. 'While we are not currently manufacturing GLP-1 APIs, we are well-equipped with peptide scale-up and fill–finish capabilities. We continue to invest in technologies to meet future market needs,' Aiyar added. Production and compliance challenges persist However, peptide manufacturing comes with its own set of challenges. 'There are production hurdles involving the availability of protected amino acids, coupling reagents, and advanced purification protocols, particularly for bulk APIs,' Varma noted. These challenges, combined with high utility costs and stringent environmental controls, add pressure to meet international compliance standards. Schemes such as the 2024 Production Linked Incentive (PLI) and Greenfield Bulk Drug Park initiatives are expected to ease some of these bottlenecks. While some CDMOs are already entrenched in the space, others are evaluating the landscape. Kashmik Formulations, for instance, is not currently working on semaglutide or related APIs, nor has it received client inquiries. However, the company sees the patent expiry of semaglutide as a potential inflection point. 'We're open to collaborations with larger players who can provide validated processes,' the company said in a statement. Diabetes burden drives urgency for scalable solutions The spike in demand is closely linked to a global epidemic of lifestyle diseases. Arushi Jain, Director at Akums Drugs & Pharmaceuticals, underscores this urgency. 'Over 100 million Indians are living with diabetes, underlining the need for scalable therapeutic solutions that address root causes such as obesity.' Akums is actively tracking developments in weight-loss APIs. As patents for semaglutide and similar molecules expire, Indian CDMOs are gearing up for a new wave of growth. Equipped with scientific expertise, evolving infrastructure, and an appetite for collaboration, the Indian peptide manufacturing ecosystem is emerging as a vital player in the global fight against obesity and metabolic diseases.
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Business Standard
29-06-2025
- Business
- Business Standard
Indian pharma eyes US gains as $63.7 bn patent cliff nears: Analysts
The Indian pharmaceutical industry is poised to benefit from a major wave of patent expiries in the US, with small-molecule drugs worth $63.7 billion expected to go off-patent between 2025 and 2029—a 65 per cent increase over the previous five years. Combined with a broader Loss of Exclusivity (LoE) opportunity across the US and EU projected to reach $180 billion by 2035, this marks a significant opening for Indian drugmakers, according to a report by Antique Stock Broking Limited. This shift is expected to spur a rise in generic launches, particularly benefiting Indian players with emerging US operations and expertise in complex generics. Firms such as Alembic Pharmaceuticals and Shilpa Medicare, which have smaller US footprints, and larger players like Cipla and Lupin, which have invested early in differentiated products such as injectables and respiratory therapies, are seen as well positioned to gain market share. With global majors like Teva, Viatris and Sandoz having closed dozens of manufacturing sites since 2018, Indian companies are stepping in to fill the supply gap. However, the opportunity is unfolding amid growing strategic discipline. Filings of Abbreviated New Drug Applications (ANDAs) in the US declined 25 per cent year-on-year. FY25 filings are projected to close around 550—down from 740 in FY24 and 857 in FY22. This signals a pivot from volume to portfolio quality, regulatory compliance and margin protection. Commenting on this shift, Nilaya Varma, Group CEO and Co-founder of Primus Partners, said, 'India's pharma exports have grown from $15 billion in 2013–14 to nearly $28 billion in a decade. With 750+ USFDA-approved plants and rising strength in complex generics and biosimilars, India is primed to lead the next wave of affordable, high-quality medicines. Tapping the $180 billion LoE opportunity will require continued focus on compliance and quality systems.' Regulatory headwinds are also easing. The share of US FDA inspections resulting in Official Action Indicated (OAI) for Indian firms has fallen from 19 per cent in 2013 to 9 per cent in 2023. Companies like Cipla are further de-risking their US supply chains by adopting multi-site manufacturing and digital quality systems. Cipla, which holds a robust US portfolio of 284 ANDA and NDA filings—175 of which are approved and 73 under review—is focusing on commercialisation-ready products, including PEPFAR-approved generics. The company is betting on complex respiratory and injectable therapies to drive growth. Pharma major Lupin, which continues to benefit globally from its blockbuster autoimmune biologic Etanercept, plans to finalise its US commercialisation strategy closer to the drug's 2029 patent expiry. Meanwhile, Sun Pharma, despite offering a conservative FY26 outlook amid global macro uncertainties, is expanding its oncology pipeline. Its recently acquired UNLOXCYT (cosibelimab) is expected to significantly contribute to US revenues. The company noted that Keytruda's upcoming patent expiry was already factored into the acquisition. UNLOXCYT targets only one of Keytruda's multiple indications, and Sun remains confident in its potential to become a meaningful contributor to its US specialty business. In parallel, Sun is also strengthening its immunotherapy portfolio through a global licensing agreement with Philogen.
