MUMBAI: The government is setting up a database Drug formulations are produced and circulated in the country in order to strengthen the monitoring mechanism and close the loopholes in the management system.
This appears to be the corrective action being taken by the government to address the issue of quality oversight and regulatory policy, after death children in Gambia last month, experts say.
Some 66 children have died after drinking cough syrup made with a “substandard hazardous ingredient” from a little-known domestic company, Maiden Pharma. Questions have been raised about quality control, implementation of good manufacturing practices in small companies, and the policies of regulatory agencies.
The government has set up an expert panel to prepare a ‘National drug The database ‘will list information about the drug, manufacturer or marketer, dosage form and strength, official sources told TOI.
Currently, there is no comprehensive national database that provides all detailed drug information. The Department of Health maintains ‘Sugam’, an index of drug licenses issued by state FDA to companies, while drug price regulator NPPA collects data on companies separately to control prices.
Since it is not obligatory for companies to provide detailed information, no government agency has succeeded in collecting robust and accurate data.
A comprehensive database is crucial not only to empower consumers but also to improve oversight mechanisms to ensure the quality and effectiveness of medicines, a government notice accessed by the TOI said. know. It can also help to uniformly administer drug regulations across the country.
The seven-member committee includes HG Koshia, Commissioner of Food and Drug Administration (Gujarat), joint pharmaceutical control division AK Pradhan (India), adjunct professor Pooja Gupta AIIMS (New Delhi), Scientist Jerian Jose ICMR and DR Gahane FDA Joint Commissioner (Maharashtra). State drug controllers from Karnataka and Himachal Pradesh were also members of the panel. The commission will examine existing databases with various central and state regulators, manufacturers and importers, the notice added.
It is expected to submit recommendations including a national database of drug formulations in three months. Compliance with regulations is a challenge for 3,000 small companies and more than 10,500 manufacturing units, leading to ineffective policy controls and gaps in quality monitoring. This is combined with a large shortage of personnel and funding of the central and state drug management mechanisms, experts added.
This appears to be the corrective action being taken by the government to address the issue of quality oversight and regulatory policy, after death children in Gambia last month, experts say.
Some 66 children have died after drinking cough syrup made with a “substandard hazardous ingredient” from a little-known domestic company, Maiden Pharma. Questions have been raised about quality control, implementation of good manufacturing practices in small companies, and the policies of regulatory agencies.
The government has set up an expert panel to prepare a ‘National drug The database ‘will list information about the drug, manufacturer or marketer, dosage form and strength, official sources told TOI.
Currently, there is no comprehensive national database that provides all detailed drug information. The Department of Health maintains ‘Sugam’, an index of drug licenses issued by state FDA to companies, while drug price regulator NPPA collects data on companies separately to control prices.
Since it is not obligatory for companies to provide detailed information, no government agency has succeeded in collecting robust and accurate data.
A comprehensive database is crucial not only to empower consumers but also to improve oversight mechanisms to ensure the quality and effectiveness of medicines, a government notice accessed by the TOI said. know. It can also help to uniformly administer drug regulations across the country.
The seven-member committee includes HG Koshia, Commissioner of Food and Drug Administration (Gujarat), joint pharmaceutical control division AK Pradhan (India), adjunct professor Pooja Gupta AIIMS (New Delhi), Scientist Jerian Jose ICMR and DR Gahane FDA Joint Commissioner (Maharashtra). State drug controllers from Karnataka and Himachal Pradesh were also members of the panel. The commission will examine existing databases with various central and state regulators, manufacturers and importers, the notice added.
It is expected to submit recommendations including a national database of drug formulations in three months. Compliance with regulations is a challenge for 3,000 small companies and more than 10,500 manufacturing units, leading to ineffective policy controls and gaps in quality monitoring. This is combined with a large shortage of personnel and funding of the central and state drug management mechanisms, experts added.
