Carving a niche for itself in innovative high-value products, finding ways to tackle increasing pricing pressures, exploration of new markets, and keeping the brand image intact will be the key drivers for the Indian pharma industry in the new year.

The year 2022 was indeed eventful for the pharma industry. In the corporate arena, many major drugmakers had launched key products, and also forged collaborations, apart from undertaking inorganic growth initiatives. The year also witnessed over a half-a-dozen major corporate deals for acquisitions and product commercialisation deals by Indian firms. Biotechnology major Biocon, through its subsidiary, Biocon Biologics, inked a pact to acquire Viatris Inc’s biosimilars business for consideration of up to ₹24,990 crore, while Dr Reddy’s entered into an agreement to  acquire Nimbus Health GmbH, a privately owned wholesaler focussing on medical cannabis in Germany in February; and Advent inked a deal to buy a majority stake in Hyderabad-based Suven Pharmaceuticals for ₹6,300 crore.  

In between, Lupin signed an agreement to acquire all rights to two inhalation medicines, Brovana (arformoterol tartrate) inhalation solution and Xopenex HFA (levalbuterol tartrate) inhalation aerosol, from Sunovion Pharmaceuticals, for a consideration of ₹622 crore.

The world’s first Intranasal Covid vaccine, iNcovacc, received approval from Indian drug regulator as a primary as well as booster dose. Post-Covid, Indian pharma’s brand image as the world’s pharmacy and vaccine maker, has received a shot in the arm. This has been reflected in the inflows Foreign Direct Investment (FDI).

FDI inflows

FDI inflows in the pharmaceutical sector, including into medical devices, was at ₹8,081 crore for the April-September period (in both pharmaceuticals and medical devices), nearly 67 per cent of what was received in FY22, according to the Department of Pharmaceuticals data. The FDI inflow last fiscal was ₹12,097 crore.

Further, the Department of Pharmaceuticals has approved 21 FDI proposals worth ₹4,681 crore for brownfield projects (between January 1 and November 30).

Among the PLI schemes approved was also one for domestic manufacturing of key starting materials (KSMs), drug intermediaries and active pharmaceutical ingredients (APIs) .The tenure of the scheme is from FY21 to FY30, and has a financial outlay of ₹6,940 crore. The Centre approved 51 applicants with committed investment of ₹4,138.41 crore. Till September, 21 projects have been commissioned with actual investment of ₹891 crore, against total committed investment of ₹844 crore.

The PLI scheme for domestic manufacturing of medical devices has a tenure of FY21-FY28, and financial outlay of ₹3,420 crore. Incentives will be given to selected companies at the rate of 5 per cent “on incremental sale of medical devices manufactured in India” for a five-year-period. 

There are four target segments under the scheme — cancer care/ radiotherapy medical devices that include radiology and imaging medical devices (both ionizing and non-ionizing radiation products) and nuclear imaging devices; anaesthetics and cardio-respiratory medical devices, including catheters; renal care medical devices and all implants, including implantable electronic devices. 

Of the 42 applicants, 21 have been approved with an investment commitment of ₹1,058.97 crore. According to the department officials, 13 projects have been commissioned for 31 products till September-end.

The PLI Scheme for pharmaceuticals is across three categories, biopharmaceuticals, phyto-pharmaceuticals and other drugs as approved; APIs, KSMs and DI (except the earlier 41 ones) and repurposed drugs - autoimmune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and antiretroviral drugs. 

The scheme, applicable between FY21 and FY29, provides for incentives on incremental sales at varying rates over the years ranging from 10 per cent to 3 per cent. An actual investment of Rs 15,164 cr. have already been made by these 55 applicants.

The year ended with few challenges for the drug exports in view of some allegations on the quality of India products in Gambia and Uzbekistan in the backdrop of ‘contamination’ levels in cough syrups exported by Maiden Pharma and Marion Biotech. The investigation is on and it’s important for India to come clean out of this controversy to sustain its brand image as an exporter of quality products to the world.