Chronicle Pharmabiz Special
"We look forward to an improvised drug approval and dispensing system"
When drugs and pharmaceuticals are in focus, Sri Lanka, the small island nation is concerned only about the reliability of imports. The country, which is completely dependent on global tenders for its healthcare products, though, follows a fairly proper system for the public distribution of drugs ever since the introduction of Cosmetics, Devises and Drugs Act No. 27 in 1980. Still, the drug pricing and dispensing are areas of concern here as involvement of qualified pharmacists in trade and the concept of drug price control are yet to emerge in the country.
However, Dr U Ajit Mendis, deputy director general of health, Department of Health Services, Sri
Lanka, assures that the government is now moving towards strengthening the drug quality assurance system, pharmacy education and also to stabilize affordable prices with fresh policy drive. Dr Mendis spoke to
C H Unnikrishnan of Pharmabiz.com in an exclusive interview in Colombo
Though drug import registration procedure in the country ensures availability of qua-lity drugs, the country still could do the least to control the retail price and also in the area of safe dispensing. Why is it so?
Ever since we introduced parallel imports by State Trading Corporation last year, we could bring down the prices of at least essential drugs. Earlier, with State Pharmaceutical Corporation, the sole agency responsible for procurement as well as distribution of drugs for public use, there was no competition in the market. But, once the STC's drug retail outlets are also present in the market strongly, the drug prices can be stabilized at a rational level.
However, drug quality regulations are very strictly observed in the country. As far as the product registrations are concerned, each and every product along with their manufacturing companies are separately scrutinized by the drug evaluation sub committee within the Directorate of Medical Technology and Supply and registered in the country.
As far as the safe dispensing of drugs are concerned, there are shortage of qualified pharmacists on the trade front. In the other three channels viz a viz government hospitals, private hospitals and institutions and dispensing doctors, this is not a crucial problem. But, in the case of retail pharmacies it is a serious issue. Absence of colleges and institutions for conducting Degree and Diploma courses in the country is the major lacunae. So the government has put forward a very strong proposal for setting up of Pharmacy Council soon to promote serious pharmacy education in Sri Lanka through affiliated colleges and universities.
The Pharmacy Council proposal has already approved by the Parliament and which would be constituted next year. Afterwards, the government would make qualified pharmacists mandatory to run pharmacies. At present, majority of the pharmacies do not have qualified pharmacists to dispense drugs.
Since the country does not have drug manufacturing as such, would it limit the employment avenues for pharmacy graduates into the trade alone?
No! They will have ample opportunities in the hospital services, drug regulatory services and also in the drug testing laboratories in the government sector. We want to expand these areas as well in a big way. Over a period of time, when the manufacturing also evolves into a considerable level, pharmacy graduates can find better opportunities in the industry as well. Apart from this, State Pharmaceutical Corporation has of late ventured into manufacturing. The manufacturing arm of the Corporation, State Pharmaceutical Manufacturing Corporation (SPMC), which is currently making 40 different products, may also emerge as a major employment avenue for the pharmacy graduates along with the small-scale manufacturers coming up in the private sector.
What is the structure of present drug regulatory system in the country?
The drug regulatory, registration and approval functions along with other medial and health services are broadly coming under the Director General of Health, who is reporting to the Ministry of Health. Under the Director General of Health, there is Director, Medical Technology and Supply, who specifically look after the drug regulations, registration and approvals.
In this department, there are separate officers responsible for seven provinces of Sri Lanka as far as the supply is concerned.
As far as the drug registration and trade policies are concerned, the decisions are taken by the government in consultation with Technical Advisory Committees constituted separately for drugs, cosmetics and medical devises and also for preventing smuggled and spurious drugs entering in the market. State Pharmaceutical Corporation mainly does the procurement and supply of drugs by inviting global tenders.
However, only the companies and products registered with the Director, Medical Technology and Supply after the scrutiny of the Drug Evaluation Sub-Committee can participate in the tenders. Even after the imports, the drug products are randomly tested in the National Drug Quality Assurance Laboratory working under the Director General of Health.