SL Pharmaceutical industry raises Concerns over Plan to Procure Medicines from India
By: Staff Writer
September 05, Colombo (LNW): Sri Lanka’s pharmaceutical industry has expressed significant concerns about Health Minister Dr. Ramesh Pathirana’s Cabinet proposal to procure 37 drugs from India under the “Jan Aushadhi” scheme.
The National Chamber of Pharmaceutical Manufacturers of Sri Lanka (NCPMSL), led by Dr. Lohitha Samarawickrema, is apprehensive about the potential negative impact on local manufacturers, importers, and patients.
A primary concern is whether these imports will bypass the National Medicines Regulatory Authority (NMRA) registration process, which is crucial for drug safety and efficacy. The chamber fears that circumventing NMRA regulations could undermine the regulatory framework and jeopardize medication safety in Sri Lanka.
Dr. Samarawickrema questioned the fairness of the proposal if Indian-approved drugs are exempt from NMRA procedures, stressing that local manufacturers and importers should also benefit from similar exemptions.
Moreover, Dr. Samarawickrema highlighted the NMRA’s requirement for site inspections of manufacturers with WHO GMP certifications, which seems to be overlooked, potentially compromising the procurement process’s transparency and credibility.
Concerns were also raised about intellectual property standards mentioned in the scheme, as the NMRA might lack the capacity for proper analytical validation, which could undermine the scheme’s integrity.
The chamber also expressed worries about HLL Lifecare Ltd., the company associated with the scheme, and the unclear relationship with the Jana Aushadhi program, raising concerns about potential pricing advantages and the selection process.
Dr. Samarawickrema emphasized the need for rigorous quality control, especially given the high rate of quality failures among Indian products, stressing that quality assurance is vital for public health protection.
There are fears that this scheme could harm local manufacturers if State purchases are concentrated through this initiative, potentially driving them out of business and weakening efforts to develop the local pharmaceutical industry.
In response, the NCPMSL recommended that all medicines be evaluated and registered by the NMRA, with local agents prioritized in procurement processes.
The chamber suggested a fast-track registration process for small-volume products and advocated for diversifying procurement sources to include local manufacturers and importers before considering international options.
Dr. Samarawickrema urged a reconsideration of the policy and called for constructive dialogue to address these concerns, reflecting the chamber’s commitment to safeguarding the interests of Sri Lankan pharmaceutical stakeholders and maintaining strong relations with India.
The NCPMSL remains opposed to the proposed policy and is prepared to take necessary steps to protect patient rights and health.
Similarly, the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) raised concerns, arguing that the proposal seems to favor a blanket importation strategy through a single company, HLL Lifecare Ltd., which could undermine the local pharmaceutical industry.
They recommended that all medicines be evaluated and registered by the NMRA, with exceptions only in rare cases.
Dr. Pathirana clarified that the Health Ministry is not planning to import unregistered or low-quality medications and that the Indian Government invited Sri Lanka to participate in the Jan Aushadhi scheme to procure drugs at fair prices after local registration.
