India should have strong regulatory system to remain leader in generic medicine, vaccines: Soumya Swaminathan | India News
NEW DELHI: Chief Scientist at World Health Organisation (WHO) Dr Soumya Swaminathan has said that it’s very important for India to have a strong regulatory system to remain a leader in the generic medicine and vaccines space.
“I think it’s going to be very important for the reputation and ultimately for India to remain as a leader in the generic medicine and vaccines space to prove beyond doubt that we have a very strong regulatory system,” Soumya Swaminathan told ANI.
India has sought more information from WHO about the initial illness, symptoms and treatment provided to the Gambian children who died allegedly after consuming contaminated cough syrups manufactured by a Sonepat-based company.
Soumya, who visited Pune in connection with an event of Developing Countries Vaccine Manufacturers Network‘s (DCVMN) 23rd annual general body, said pharmaceutical contamination is a serious issue and should be taken seriously.
“WHO actually provided the report based on the investigation that was done to prove that it was because of the Diethylene glycol (DEG) contamination, it’s a serious issue, I think it has to be taken very seriously,” she said.
“We have the central and the state regulators. We need to look at the rules of operation and see how we harmonise these,” she added.
The expert said drug regulators of different states can actually work together, do cross-inspections on products sold in the country and exported to other countries.
“So, I think there’s already been a number of recommendations made into strengthening and identifying some of the weaknesses in the current system and strengthening it,” Soumya Swaminathan said.
DCGI had last week written to WHO following the Expert Committee meeting on the ‘adverse events’ reports on the deaths of children in Gambia and said that clinical features and treatment received by the children shared so far were inadequate to determine the aetiology.
“I think it’s going to be very important for the reputation and ultimately for India to remain as a leader in the generic medicine and vaccines space to prove beyond doubt that we have a very strong regulatory system,” Soumya Swaminathan told ANI.
India has sought more information from WHO about the initial illness, symptoms and treatment provided to the Gambian children who died allegedly after consuming contaminated cough syrups manufactured by a Sonepat-based company.
Soumya, who visited Pune in connection with an event of Developing Countries Vaccine Manufacturers Network‘s (DCVMN) 23rd annual general body, said pharmaceutical contamination is a serious issue and should be taken seriously.
“WHO actually provided the report based on the investigation that was done to prove that it was because of the Diethylene glycol (DEG) contamination, it’s a serious issue, I think it has to be taken very seriously,” she said.
“We have the central and the state regulators. We need to look at the rules of operation and see how we harmonise these,” she added.
The expert said drug regulators of different states can actually work together, do cross-inspections on products sold in the country and exported to other countries.
“So, I think there’s already been a number of recommendations made into strengthening and identifying some of the weaknesses in the current system and strengthening it,” Soumya Swaminathan said.
DCGI had last week written to WHO following the Expert Committee meeting on the ‘adverse events’ reports on the deaths of children in Gambia and said that clinical features and treatment received by the children shared so far were inadequate to determine the aetiology.
