Private pharmaceutical companies importing vaccines will be required to submit a “Lot Release Certificate” from January 1, 2014 before marketing or selling in an attempt to streamline and ensure regulations are maintained, Director of the Cosmetic Devices and Drugs Regulatory Authority (CDDRA) Dr. Hemantha Beneragama told ‘The Nation’.
“The practice in the past had been to visit the local clinics for vaccines, however, we have noticed that nowadays at least 20% of Sri Lankans seek the services of a private hospital for immunization,” observed Dr. Beneragama. “From January next year, we are evolving a system where all private pharmaceutical companies will have to submit a certificate called the “Lot Release Certificate” before marketing or selling.”
He added that the system is already in place for the government sector, but it will be made mandatory for private companies as well. “The certificate is issued by the Medical Research Institute for which the companies will have to submit samples.”
Several other regulatory mechanisms on the import of drugs will come into effect when the new Drug Act is passed, he elaborated. “The final draft of the Act is at the Attorney General’s Department and once approved by the Cabinet, the Act will strengthen existing laws governing the imports of drugs and enforce several new ones.”
“From the beginning of next year companies will have to provide information about their API (Active Pharmaceutical Ingredients) on an annual basis. It will be made mandatory to declare and provide documentary evidence that their API is in conformity with GMP (Good marketing practices).”
Dr. Beneragama added that the Cosmetics Devices and Drug Regulatory Authority will also continue to inspect drug supplying factories in India.
“Ninety percent of the drugs imported are from India and there have been several instances where some had to be suspended and others banned. Last year, out of the 12 facilities which we inspected in India, we banned one which was operating without license while the other had quality issues.” he disclosed.
He further revealed that 56 products of an Indian factory which supplied an important drug had been banned when it was found that some of the vials were sub standard. Also, 14 drugs of another company using contaminated water were also banned.”
He added that the authority would continue further inspections this year.
Source: The Nation