The Rajya Sabha on Wednesday, August 8, witnessed two written responses highlighting the steps taken by the Indian government to ensure that the quality of drugs, especially cough syrups, in the nation is maintained.
In his response, Minister of State for Chemicals and Fertilisers Bhagwanth Khuba pointed at provisions under the Drugs and Cosmetics (Amendment) Act, 2008 which lay out regulatory measures to ensure the quality of medicines in India. These include:
#
Stringent penalties for manufacturers of spurious and adulterated drugs
# Cognisable and non-bailable offences
# Special courts in states and Union Territories for the trial of offences under the acts for speedy disposal
# Required submission of bioequivalence study results along with applications for manufacturing licenses of oral dosage form drugs
# Mandatory joint inspection of manufacturing establishments by the Drugs Inspectors of the Central Government and State Government
# Required submission of evidence of stability and safety of excipients to the State Licensing Authority before being granted a manufacturing license by the authority
# Increased number of sanctioned posts in the Central Drugs Standard Control Organisation (CDSCO) in the last 10 years
# Expert advice and activity coordination by the CDSCO, State Drug Control Organisations, Drugs Consultive Committee, and State Drug Controllers
Furthermore, Health Minister Mansukh Mandaviya wrote specifically about cough syrups and regulatory measures by the administration to ensure their quality. He noted that manufacturers are required to comply with the conditions of the licence granted under the Drugs and Cosmetics Act to manufacture any drugs for sale and distribution in India
In numbers, these are the updates Mandaviya provided:
Action taken | Number of instances |
Risk-based inspections | 162 |
Show cause notices | 143 |
Stop production order | 40 |
Cancellation and suspension of product/section licenses | 66 |
Warning letters | 21 |
FIR lodged | 1 |
Persons arrested | 3 |
Cough syrup samples analysed | 900+ |
Mandaviya also pointed out that the Ministry of Commerce and Industry on May 22 issued a notification mandating cough syrup manufacturers to get a certificate of analysis from a government-approved laboratory before exporting their products.
Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!