Updated on 24 July 2012
In April 2011, Sri Lankan authorities blacklisted 10 Indian drug companies (names not disclosed) for violating tender procedures, supplying substandard products and disregarding delivery schedules, which are requirements stipulated for their registration with the ministry. The health ministry ordered the Director General of Health Services to cancel the tenders awarded to the companies and acquire drugs from other countries to counter the shortage of quality drugs in government hospitals, despite India's moves to avert the ban.
Mr Nimal Dias Jayasinha, managing director, Emerchemie NB, (Ceylon) said the government decision has created some unsavoury scenarios. "For example, the originator products will now have a monopoly situation and will naturally opt to demand prices of their choice. It has already begun to happen - a wholly immoral scenario of putting the poor patient to the sword," he points out.
Calling the government decision an illogical stance, he said, "If the products available in India to treat a population of 1.3 billion people is considered by the highly advanced medical fraternity a threat and if such action has also the blessings of the World Health Organization (WHO), why should the patients in Sri Lanka be deprived of such medicines that have effectively been tried and tested in Sri Lanka for over five years."
Recalling the events, Mr Adrian Basnayake, former president of Sri Lanka Chamber of Pharmaceutical Industry, says, "The Cosmetics, Devices & Drugs Regulatory Authority (CDDRA), the regulatory body of Sri Lanka, by way of their circular dated December 10, 2010, informed the industry that it intends to conduct a review of the registered biosimilar pharmaceuticals using recombinant technologies in its production. The companies were requested to re-submit details, such as name of drug, dosage form, strength and type of registration (full or provisional) and registration status worldwide, especially if the product is registered in the US, UK, Australia, EU (MEA), New Zealand, Canada and Japan that the CDDRA considers as reference countries."
The CDDR wanted to know if clinical trial data had been submitted with the original drug application. It was also required to declare if the product had been rejected in any country and if the product is actually marketed in Sri Lanka at that time. The companies were, thereafter, given time to submit clinical trial data, ideally comparative efficacy and safety data with the originator before Feb 28, 2011, to retain the registration. The Sri Lanka Chamber of Pharmaceutical Industry made representations to the CDDRA and the technical advisory committee of the Ministry of Health to reconsider this deadline and obtained time till February 28, 2012, as most member companies were of the opinion that the time given was too short to respond in a meaningful way.