WHO Pharmaceutical Manufacturing Classification: SL Pharma aims to jump to Level 03 from Level 01

  • 60% of local pharma requirement to be manufactured locally

By Imsha Iqbal 

The Government is planning to level up Sri Lanka’s pharmaceutical manufacturing sector classification to Level 3 from its current Level 1 status, State Ministry of Production, Supply and Regulation of Pharmaceuticals Secretary Dr. R.M.S.K. Ratnayake stated. 

“According to the World Health Organisation (WHO) classification, we are at Level 01,” he stated, adding that the Government is on the path to advancing to the next level in pharma manufacturing. 

Thus, the Level 02 and Level 03 statuses are yet to be achieved, however, under the direction of the National Medicines Regulatory Authority (NMRA), he said that the process can be achieved within a period of two to three years in accordance with the WHO guidelines. 

Dr. Ratnayake made this statement during the Promoter Institutional Session titled “Deep Dive Session on Pharma Manufacturing Destination”, held on the third day of the Sri Lanka Investment Forum 2021 (SLIF).

NMRA is the apex body in regulating medicines, medical devices, borderline products, clinical trials, and cosmetics, as well as handling the functioning of the National Medicines Quality Assurance Laboratory (NMQAL), and also is in charge of ensuring the quality of medicinal products.

He also highlighted that the Government expects to increase domestic medicine manufacturing up to 60%. Sri Lanka, at the moment, manufactures only 15% of its local demand for medicine.

In the first day of the forum, Board of Investment Chairman Sanjaya Mohottala stated that the Sri Lankan Government has taken measures to build a strong local pharmaceutical industry to cater to the country’s needs, and to build a new export vertical, taking advantage of the skilled talent pools and existing pharma operations, as well as the geopolitical shifts we have all seen and experienced.

“A state-of-the-art 400-acre pharma zone is being built adjoining the Hambantota

Port and the international airport, with easy access to both sea and air logistics. The

environmental and other pre-clearances allow for any type of drug manufacturing to take place, from APIs to generics to oncology, thereby reducing set up time significantly for any potential investor. To support this strategic initiative, the Government is offering generous tax breaks of up to 10 years, and customised incentive packages will be offered for larger investors,” he added.