India Pharma News: Generics-Only Guidelines on Hold; Torrent/Cipla Deal; Lupin BI Brands Acquisition


A roundup of some of the top stories from the Indian pharma industry including the suspension of the National Medical Commission’s (NMC) guidelines making the prescription of generic drugs mandatory; the government’s revision of Good Manufacturing Practices (GMP) in light of deaths linked to Indian-made cough syrups; Torrent Pharma’s new stake in Cipla; Lupin’s acquisition of Boehringer Ingelheim diabetes brands, and the partnership between Dr. Reddy’s and Shanghai Junshi Biosciences.


Order directing doctors to prescribe only generic medicines put on hold (India Today)

The orders issued by the National Medical Commission (NMC) which had barred doctors from prescribing medicines other than generic drugs has been put on hold with immediate effect. The decision was made after the Indian Medical Association (IMA) and the Federation of Resident Doctors Association approached the Centre and Union Health Minister Mansukh Mandaviya.

The National Medical Commission’s Registered Medical Practitioner (Professional Conduct) Regulations, 2023, had made the prescription of generic drugs mandatory for doctors, along with other directives. The regulatory body had stated that since generic medicines are 30 to 80 per cent cheaper than branded drugs, this new rule would lower healthcare costs.


India pharma exports soaring despite cough syrup deaths, trade body says (Reuters)

India’s pharmaceutical exports this fiscal year are set to grow nearly twice as fast as last year to hit sales of USD 27 billion, driven by strong U.S. buying, a government-backed trade body told Reuters, despite deaths linked to Indian-made cough syrups.

The robust forecast comes against the backdrop of earlier concerns from the government that last year’s deaths of dozens of children in Gambia, which the World Health Organization (WHO) linked to drugs made in India, had “adversely impacted the image of India’s pharmaceutical products across the globe”.

Revised manufacturing rules for drug firms: what changes, and why (The Indian Express)

The government recently directed all pharmaceutical companies in the country to implement the revised Good Manufacturing Practices (GMP), bringing their processes at par with global standards. Larger companies with a turnover of over Rs 250 crore have been asked to implement the changes within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore have been asked to do so within a year.

This comes at a time when India is promoting itself as the global manufacturing hub for generic medicines.


Torrent Pharma joins race to acquire stake of Cipla promoters (Business Today)

In what could be a significant change in the pharma sector in India, Ahmedabad-based Torrent Pharma is likely to enter the race to acquire the Hamied family’s stake in Cipla, a report said on Wednesday.

With this, Torrent Pharma will directly compete with bigwigs like Blackstone and Baring Private Equity Asia-EQT. Torrent has hired JP Morgan to work on the deal.


Lupin acquires Boehringer Ingelheim’s brands Ondero and Ondero Met to expand diabetes portfolio in India (India Pharma Post)

Global pharma major Lupin Limited (Lupin) announced the acquisition of diabetes brands Ondero and Ondero Met, from Boehringer Ingelheim International, including the trademark rights associated with these brands. Lupin has been marketing ONDERO® and ONDERO MET since 2015 in the Indian market as part of a comarketing agreement with Boehringer Ingelheim India.

This acquisition strengthens Lupin’s commitment to providing superior treatment options for patients navigating the complexities of diabetes.


Aurobindo to launch HIV triple combination product for children living with HIV in low and middle-income countries (India Pharma Post)

Aurobindo Pharma Limited has announced USFDA tentative approval under the PEPFAR program for the first generic dispersible tablet formulation of the fixed dose combination Abacavir 60mg + Lamivudine 30 mg + Dolutegravir 5 mg (pALD), for the treatment of children living with HIV weighing 6 kg to <25 kg and aged at least 3 months.

Aurobindo has a paediatric dolutegravir voluntary licence with ViiV Healthcare, enabling development and supply of this product in 123 Low and Middle-Income Countries (LMIC), including India. This is one of the fastest approvals for a generic combination product following approval of the innovator formulation, with ViiV having secured USFDA approval in March 2022. Aurobindo’s product is already filed with the Drugs Controller General of India (DCGI) and is expected to be approved soon.


Venus Remedies launches flagship R&D drug Elores in Oman (BioSpectrum Asia)

India-based Venus Remedies has launched its flagship R&D drug Elores in the $1.4 billion pharmaceutical market in Oman.

Clinically proven to be one of the best drugs against ICU infections caused by multidrug-resistant extended spectrum beta lactamase (ESBL) and metallo beta lactamase (MBL)-producing gram negative bacteria, Elores is effective against bacterial strains resistant to the last-resort carbapenem class of antibiotics.

The antibacterial market in Oman is worth $7.5 million, and Elores is looking to capture 0.5 per cent of this segment ($0.375 million) by year 2025. Oman has alarmingly high rates of ESBL and MBL-producing gram negative infections, as high as 54 per cent. About 63.4 per cent of K. pneumoniae isolates from Oman are multi-drug resistant and produce ESBL against which Elores exhibits remarkable efficacy.


Alembic and Aurobindo issue US drug recalls, citing quality and production issues (Fierce Pharma)

Alembic and Aurobindo Pharma, the U.S. unit of India’s Aurobindo, issued voluntary recalls of products because of quality issues and manufacturing deficiencies, respectively. Alembic recalled 82,400 bottles of the bacterial eye infection treatment tobramycin, according to an advisory posted on the FDA website. The nationwide recall kicked off July 27.

In its notice, the company said the action was taken due to “failed impurities/degradation specifications.”


Junshi Biosciences, Dr. Reddy’s Partner to Develop Toripalimab in 21 Countries (Contract Pharma)

Shanghai Junshi Biosciences Co., Ltd, will collaborate with Dr. Reddy’s Laboratories to develop and commercialize toripalimab, the anti-PD-1 monoclonal antibody in Latin America, India, South Africa, and at the election of Dr. Reddy’s, also in Australia, New Zealand and other countries.
Under the license and commercialization agreement, Junshi Biosciences will grant a license to Dr. Reddy’s to develop and exclusively commercialize toripalimab in Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay, India and South Africa. Dr. Reddy’s may elect to expand the scope of the license to cover Australia, New Zealand and nine other countries.

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