Local pharma manufacturers raise concerns on Indian Jan Aushadhi scheme 

• NCPMSL asks if proposed imports from India will bypass NMRA registration process
• Points out the need for rigorous quality control due to high rate of quality failures among Indian products
• SLCPI argues proposal seems to favour a blanket importation strategy through single company and may undermine SL’s pharmaceutical industry
• Health Minister assures all drugs brought to SL under scheme will be first registered with NMRA and MoU will be signed soon

Sri Lanka’s pharmaceutical industry has expressed serious concerns regarding a recent Cabinet proposal submitted by Health Minister  Dr. Ramesh Pathirana on procurement of 37 drugs from India under the “Jan Aushadhi” scheme.

The National Chamber of Pharmaceutical Manufacturers of Sri Lanka (NCPMSL) President Dr. Lohitha Samarawickrema in a formal letter to Dr. Pathirana last week, expressed the chamber’s apprehensions about the potential adverse effects of the scheme on local pharmaceutical manufacturers, importers and patients. He said one major concern is if the proposed imports from India will bypass the National Medicines Regulatory Authority (NMRA) registration process. The chamber said it fears that such a bypass could undermine the regulatory framework that is crucial for ensuring drug safety and efficacy in Sri Lanka.

Dr. Samarawickrema also questioned the fairness of the scheme, particularly if drugs approved by Indian authorities are exempt from NMRA procedures. He emphasised that similar exemptions should be available for local manufacturers and importers to ensure a level playing field.

He noted that the NMRA’s requirement for site inspections of manufacturers with WHO GMP certifications appears to be overlooked, raising concerns about the transparency and credibility of the procurement process.

Another issue highlighted was the acceptance of intellectual property standards mentioned in the documents. Dr. Samarawickrema noted the NMRA currently lacks the capability for proper analytical validation of these standards, which could compromise the integrity of the scheme. “The relationship between HLL Lifecare Ltd., which is mentioned in the scheme, and the Jana Aushadhi program is also unclear, leading to concerns about the selection process and potential pricing advantages,” he said. 

Dr. Samarawickrema further pointed out the need for rigorous quality control, given the high rate of quality failures among Indian products. He stressed that quality assurance must be a priority to protect public health. The chamber also expressed concerns about the impact of the scheme on local manufacturers, who may face severe repercussions if State purchases are concentrated through this initiative. The NCPMSL argued that this could drive local manufacturers out of business and undermine Government efforts to develop the local pharmaceutical industry.

To address these concerns, the NCPMSL recommended that all medicines be evaluated and registered by the NMRA, and that procurement should prioritise local agents whenever possible. They also suggest implementing a fast-track registration process for small-volume products and ensuring adequate lead time for production or imports to manage quality control and logistics. Additionally, the chamber advocates for diversifying procurement sources to include local manufacturers and importers before considering international options.

Dr. Samarawickrema called for a reconsideration of the policy in its current form and urged a constructive dialogue to address these issues. The letter underscores the chamber’s commitment to protecting the interests of Sri Lankan pharmaceutical stakeholders and maintaining strong relations with India. The NCPMSL said it remains firm in its opposition to the proposed policy and is prepared to take necessary steps to safeguard patient rights and health.

Meanwhile, the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) also raised similar concerns regarding the recent Cabinet proposal on medicine procurement from India under the scheme. 

The SLCPI argued the proposal seems to favour a blanket importation strategy through a single company, HLL Lifecare Ltd. and may undermine the local pharmaceutical industry.

The SLCPI recommended that all medicines must be evaluated and registered by the NMRA, with exceptions only in rare cases of lifesaving or epidemic situations. “Additionally, adequate lead time for pharmaceutical production and consideration of other countries for procurement are advised to ensure quality and support local industry,” SLCPI said. The chamber also said it is currently firmly opposed to the proposal.

According to the Jan Aushadhi website, the program is a public welfare initiative by the Government of India, launched by the Department of Pharmaceuticals. Its goal is to offer quality medicines at affordable prices to the general public. The scheme focuses on providing generic drugs, which, while priced lower, match the quality and efficacy of more expensive branded medications.

Addressing the media on Friday, Dr. Pathirana clarified that the Health Ministry is not currently pursuing emergency procurement of drugs nor planning to import any unregistered or low-quality medications. He explained that the Indian Government has invited Sri Lanka to participate in the Jan Aushadhi scheme. The Cabinet paper under discussion pertains to this scheme, which allows Sri Lanka to procure drugs at fair prices only after they are registered in the country. Dr. Pathirana also noted that a Memorandum of Understanding (MoU) will be signed to formalise this arrangement in the future.