Top stories from Indian pharma including Sanofi India’s plans to demerge its healthcare businesses; Junshi Biosciences and Dr. Reddy’s anti-PD-1 monoclonal antibody partnership; Venus Remedies’ new oncology approvals; CORONA and Ferring’s maternal health agreement and Ipca Laboratories and Sun Pharma’s quality issues.
Zydus Lifesciences reports smallest profit in 14 quarters (Reuters)
India’s Zydus Lifesciences Ltd reported its smallest profit in 14 quarters, hurt by a goodwill impairment charge and costs related to shutting operations at one of its manufacturing units. The pharmaceutical company reported a 25 percent fall in its fourth-quarter consolidated net profit to 2.97 billion rupees (USD 36.32 million), its smallest profit since the second quarter of fiscal 2019.
Sanofi India to demerge healthcare businesses (Indian Pharma Post)
The Board of Directors of Sanofi India Limited (SIL) has approved the Scheme of Arrangement as per applicable provisions of the Companies Act, 2013, and other applicable laws, between SIL and its wholly owned subsidiary Sanofi Consumer Healthcare India Limited (currently under the process of incorporation) (SCHIL) to demerge SIL’s consumer healthcare business into a legal entity, i.e., SCHIL, subject to approval by shareholders and regulators upon incorporation of SCHIL. This decision will open new gates for the India business and employees in a value-driven move to accelerate growth for both the pharmaceuticals business (SIL) and consumer healthcare business (SCHIL) in India.
India considers policy change after cough syrup deaths: PM Modi’s office (The Hindu)
India is considering a change to its pharmaceutical industry policy after cough syrups made in the country were linked to the deaths of children overseas, according to a document from Prime Minister Narendra Modi’s office, which noted that “important things” about the industry had been “overlooked”. A brainstorming session was held in the southern Indian city of Hyderabad “to find a solution to exported cough syrups that killed children,” PM Modi’s office said in the document dated May 15 and reviewed by Reuters.
Pharma companies seek price ceiling exemption for low-cost medicines (Business Standard)
As the government is moving to impose a price ceiling on essential medicines, the pharmaceutical industry is looking for an exemption from ceiling price for all low-priced formulations up to Rs 5 per unit, The Economic Times (ET) reports. Citing people aware of the developments, the newspaper reported that the industry lobby met government officials to request an exemption from the implementation of trade margin rationalisation (TMR) for formulations that cost less than Rs 10 per unit as well. The industry and the government are on the same page on TMR, however, the industry wants it to be implemented in a phased manner.
Junshi Biosciences, Dr. Reddy’s to develop and commercialise oncology drug in 21 countries (BioSpectrum Asia)
Shanghai Junshi Biosciences Co. has collaborated with Indian pharmaceutical firm Dr. Reddy’s Laboratories to develop and commercialise toripalimab, the anti-PD-1 monoclonal antibody in 21 countries. Under the license and commercialisation agreement, Junshi Biosciences will grant a licence to Dr. Reddy’s to develop and exclusively commercialise toripalimab in Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay, India and South Africa.
Venus Remedies bolsters position in oncology space with marketing approval from Philippines, Iraq (BioSpectrum Asia)
Close on the heels of the marketing approval for a key cancer drug from the UK Medicines and Healthcare products Regulatory Agency (MHRA), Indian pharmaceutical firm Venus Remedies, a well-known provider of affordable cancer drugs worldwide, has further consolidated its position in the oncology space with marketing authorisation for two more widely used cancer drugs from Philippines and Iraq.
CORONA Remedies collaborates with Ferring Pharmaceuticals to commercialize maternal health products in India (Indian Pharma Post)
CORONA Remedies Private Limited (CORONA) has entered into an agreement with Ferring Pharmaceuticals Pvt. Ltd. (Ferring), a subsidiary of Switzerland-based global biopharmaceuticals company Ferring Pharmaceuticals, to commercialize unique and innovative products in the field of Maternal Health & Urology. The collaboration between CORONA and Ferring will cater to patients across India with innovative products including a few global brands to address the unmet therapeutic needs in maternal health and urology.
Ipca Laboratories cited for quality issues at India facility that produces API (Endpoints)
The FDA identified several quality issues at a plant in India owned by Ipca Laboratories that makes active pharmaceutical ingredients. In the seven-page inspection report, the FDA cited several issues during an inspection at a facility in Piparia, India, that took place between April 18 to 26.
FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists (Fierce Pharma)
On the heels of an FDA citation and export halt at Sun Pharma’s Mohali, India, manufacturing operations, the U.S. drug regulator is making clear that its demands for corrective actions are nonnegotiable. The FDA has ordered Sun to enlist a current good manufacturing practices (CGMP) expert as the Indian drugmaker works to right the ship at its Mohali site, where the company last summer received a six-observation Form 483 tied to inadequate testing and on-site record-keeping.
