In the latest blow to Indian pharma’s reputation, the European Medicines Agency (EMA) has recommended the suspension of marketing authorisations for a large number of generics tested by Indian CRO Synapse Labs. While the Indian government has taken steps to regulate the industry and improve quality, including a new Drugs, Medical Devices, and Cosmetics Bill proposal, and leading pharma organisations attempt to maintain standards, the industry continues to grapple with quality issues.
Damaged Credibility
After the alarm triggered by Indian-origin cough syrups that caused multiple deaths of children, the Indian pharma industry has been under fire with respect to its quality standards. In addition to the cough syrup episode, in 2023 the FDA issued several warning letters to Indian companies relating to numerous corrective and preventive action (CAPA) compliance concerns. Intas Pharmaceuticals for one was called out in August because it “failed to ensure reliability of data relating to the quality of medicines produced at your facility.”
Reliable data looks to continue to be an issue as the latest chapter the country’s struggle with quality comes with EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation based on questionable data from Synapse Labs on behalf of EU companies. After Spanish regulators inspected the company’s facilities and found non-compliance with good clinical practice (GCP) and “serious concerns about the validity and reliability” of the clinical data generated by Synapse, the CHMP initiated a review that has led to its current suspension recommendations.
Of the 400 medicines tested by Synapse Labs on behalf of EU companies, the CHMP found sufficient supporting data to demonstrate bioequivalence [demonstrating that the generic medicine releases the same amount of active substance as the reference medicine] for only some 35 of the medicines concerned. Marketing authorisation for those drugs will be maintained and the final decision about the others will be with the European Commission.
Steps to Ensure Quality
In light of these tests on the Indian pharma industry’s credibility, the country’s Health Ministry has drawn up a new Drugs, Medical Devices, and Cosmetics Bill, which after much delay is expected to be introduced soon.
The bill is aimed at regulating and supervising everything from production and distribution to importation and ensure standards in quality, safety, efficacy, and performance, as well as regulate clinical trials for new drugs. Set to replace the Drugs and Cosmetics Act of 1940, the new legislation also looks to build a more transparent regulatory regime with the centralised regulation of drugs.
Both the industry and patient groups are anxious for the bill to come into effect. “The ground-breaking initiative by the Health Ministry is positioned to enhance both the pharmaceuticals and medical devices industries, simultaneously bringing benefits to patients. The compelling nature of the bill, with its diverse provisions emphasising patient safety, highlights the need for its prompt passage,” said Dr. Rajiv Desai, senior technical advisor, Quality & Regulatory, Indian Pharmaceutical Alliance.
Quality serves as the bedrock of the pharmaceutical industry, and the bill’s promotion of innovation and research and development (R&D) is poised to fortify the country’s quality management systems
Anubha Taneja Mukherjee, member secretary, Thalassemia Patients Advocacy Group
“Quality serves as the bedrock of the pharmaceutical industry, and the bill’s promotion of innovation and research and development (R&D) is poised to fortify the country’s quality management systems. By fostering an environment that nurtures innovation and R&D, this bill is anticipated to serve as a catalyst for elevating the industry’s standards and practices in ensuring top-notch quality across the board,” said Anubha Taneja Mukherjee, member secretary, Thalassemia Patients Advocacy Group.
Beyond government initiatives, industry organisations such as the Indian Drug Manufacturers’ Association (IDMA) are promoting quality and helping their member companies meet global standards. “Recently, we’ve been revising the Good Manufacturing Practices (GMP), and IDMA was the sole association mandated by the CDSCO and DCGI to conduct nationwide meetings to sensitize manufacturers,” said secretary general Daara Patel. For Patel, bolstering quality is an ongoing effort. “While we’ve been devoted to maintaining quality, the objective is to ensure everyone comprehends and renews their pledge to excel further.”
For another industry body, the Indian Pharmaceutical Alliance (IPA), quality assurance is a major focus area. “[We] focus on driving excellence in pharma by consistently elevating quality standards to position India as a global benchmark for excellence,” asserted secretary general Sudarshan Jain.
Jain is also quick to underline the progress the country has made in terms of quality. “With more than 600 US FDA-approved facilities, India has made significant strides in ensuring the quality of its medicines,” he maintained.
