Urgent need to speed up approvals of locally-produced drugs
One of Sri Lanka’s top pharmaceutical manufacturing facilities is urging the government to streamline the approval of locally-manufactured vital drugs and medicines, saying speed is the essence as it would save lives.
At the Morison’s 5.5 acre world-class pharma manufacturing plant located in the SLINTEC Nanotechnology zone at Homagama, the company currently produces 6-7 drugs mainly for non-communicable diseases like diabetes and heart ailments, sourcing raw material from India and China. In total the company, part of the conglomerate Hemas Group, produces over 50 drug and medicine varieties – including the popular Lacto Calamine and gripe mixture mostly at the Morison’s decades-old Mutwal plant in Colombo.
“We have submitted for approval 10-12 Morison branded drugs to the National Medicine Regulatory Authority (NMRA) but the process takes 12 to 18 months to get a drug approved. There is too much paper work and by the time these approvals are given, the cost has also gone up,” lamented Dinesh Athapaththu, Managing Director -Morison Ltd after the Sunday Times Business was taken on a 90-minute tour of the entire facility where quality standards and stringent, secure and sterile processes are in place.
The walk through the highly sterile plant revealed the effort made in quality checks on raw material, efficacy, impurities, etc of the drugs produced here. The plant has modern air lock doors to avoid contamination and a 24-hour cooling system and temperature control. While it works one shift producing millions of tablets, it has the capacity to do two shifts and increase production by another 50 per cent. Upendra Silva – the company’s Head of Quality and Technical Services, Menaka Pethiyagoda – Head of Operations, and Ms. Rukshani Perera – Head of Strategy were associated with the visit.
Mr. Athapaththu said that as a local manufacturer, they have a huge responsibility to ensure a quality and safe product to the consumer. “We have stringent quality control and efficacy standards in place,” he said during a boardroom discussion in the modern plant, designed with Indian expertise, adding: “Regulation is fine and necessary but the government should speed up the approval of drugs process as this is a sector that produces life-saving drugs for the population.”
In total, there are 16 local pharma manufacturing, including Morison, competing for a slice of the government intake of around 15 per which is made up of local production while the rest of the demand is met by imports (around 60 per cent).
He said the company invested US$18.5 million (Rs.4 billion) in the plant in 2019-2020 with over 100 staff including only 30 operators as the production process is without any human contact and machine-driven, and the investment was based on a buy-back arrangement by the government with local producers..
However that system collapsed when the State Pharmaceuticals Manufacturing Corporation launches joint ventures with private producers and these benefitted most in the buyback arrangement. “We have lost significant business. Our business model and assumption was based on the buyback arrangement and now because of this crisis, our return on investment would take 10 years compared to 6-7 years earlier,” he said.
The strategy in inviting the media to visit the facility is to prove to the world that Sri Lankan companies can produce lifesaving drugs with the highest
quality standards, eventually reduce the demand for imported drugs and also save foreign exchange. Morison started its Mutwal plant in the late1950s when local manufacturing started to take root in Sri Lanka. In those 70 odd years since then India produces 100 per cent of its drugs required for the local market, Bangladesh 95 per cent, Pakistan 70 per cent while in Sri Lanka its only 15 per cent. “There is huge scope to expand the local manufacturing base to fill the gap now met with imported drugs and brands,” he said.
He said after the buyback arrangement collapsed, they have had to build local brands. “We want to be the number 1 local producer by 2030 as a truly Sri Lankan brand, managed and owned by Sri Lankans. We follow an ethical approach in manufacturing, marketing, dealings with government and the medical profession” he added.
Lamenting about the excess of drugs in the market place when one drug/molecule (in medical parlance) has 40-50 different types, he says there needs to be some streamlining process here, adding: “The government needs to encourage this critical industry as it saves lives and ensures health and well-being which is the wealth of a nation.”
Hitad.lk has you covered with quality used or brand new cars for sale that are budget friendly yet reliable! Now is the time to sell your old ride for something more attractive to today's modern automotive market demands. Browse through our selection of affordable options now on Hitad.lk before deciding on what will work best for you!