Context: Recent data from the Central Drugs Standard Control Organisation (CDSCO), shows that at least 6% of cough syrup samples from 54 Indian manufacturers failed a mandatory quality test for export.
Cough Syrup Manufacturers Fails Quality Test For Export
- Gambia, Uzbekistan, Cameroon, and the World Health Organisation (WHO) raised red flags after children who had these drugs died prompting the Central government to take remedial action
| Deaths in the Gambia due to faulty cough Syrups
The World Health Organisation (WHO) connected the deaths of at least 70 children in the Gambia last year to medications manufactured by Indian pharmaceutical company Maiden Pharmaceuticals that were tainted with ethylene glycol (EG) and diethylene glycol (DEG), toxins typically used as antifreeze and industrial solvents. |
- Faulty Samples: According to government data, of the 385 samples tested 51 were found to be NSQ (not of standard quality), while 29 out of 502 samples failed the quality test in another lab.
- Extent of Exports: India exported cough syrups worth USD 17.6 billion in 2022-23.
Drug Regulation in India
- Drug Cosmetics Act 1940: On April 10, 1940, the Drug & Cosmetics Act was passed to oversee medication imports into India, ensuring that no substandard or counterfeit drugs enter the country.
- Drug and Cosmetics Rules, 1945: Drug and Cosmetics Rules, 1945 categorized the drugs into schedules and provided regulations for the sale, storage, and prescription of each category.
- Central Drugs Standard Control Organisation (CDSCO)
- Nodal Ministry: Ministry of Health & Family Welfare, Government of India.
- It is the National Regulatory Authority (NRA) of India.
- Functions:
- CDSCO is responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, and control over the quality of imported Drugs in the country.
- CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids
Must Read: India Pharma Products And Drug Safety
Pharmaceuticals Regulation: Over Exports
- Good Manufacturing Practices (GMP): They cover things like the design of the manufacturing facility, training of employees, and quality control procedures.
- Drugs and Cosmetics Act: It controls the import, production, distribution, and sale of export pharmaceutical products and cosmetics.
- Schedule M: Schedule M is a part of the Drugs and Cosmetics Rules. It explains the detailed requirements for manufacturing and quality control of medicines.
- Pharma Export-Import Laws and Regulations: These rules include getting the required Importer-Exporter Code (IEC) and following export documentation requirements.
New Testing Parameters for Cough Syrups to be Exported From India
- Certificate of Analysis (CoA): The government has introduced updated testing parameters for cough syrups slated for export from India, necessitating the generation of a Certificate of Analysis (CoA) from designated laboratories.
- Designated Labs: The specified central government labs include the Indian Pharmacopoeia Commission, regional drug testing lab (RDTL – Chandigarh), and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments.
News Source: The Hindu
December 9, 2023
