Two labs in India take on the bulk of testing for cough syrup samples for export

Subject :Science and Tech

Section: health

Context:

The Directorate General of Foreign Trade under the Department of Commerce, Ministry of Commerce and Industry issued a notification early this year for amendment in the export policy for cough syrups, making it compulsory from June 1 for cough syrup manufacturers to secure a certificate of analysis from a government-approved laboratory before exporting their products.

Details:

The order came following a World Health Organization (WHO) product alert in cases of syrup products being exported from India.
The country has 15 Central and State-run laboratories engaged in cough syrup sample testing, including the Regional Drugs Testing Laboratory, Kerala.
One Central and one State testing laboratory in India are currently bearing the bulk of cough syrup sample analyses brought in for testing before their export.
- These two centers are: CDTL, Mumbai; and the Food and Drug Laboratory, Gujarat.
CDSCO and the Ministry of Health and Family Welfare under the Drugs and Cosmetics Rules 1945, have brought in various measures to maintain the standard of drugs being exported from India.
- The amendments include mandating that before the grant of a manufacturing license, the manufacturing establishment is to be inspected jointly by the drugs inspectors of the Central government and State government.
- The number of sanctioned posts in the CDSCO has been significantly increased in the last 10 years, and an amendment has also been brought in, making it mandatory for applicants to submit evidence of stability, safety, etc. to the State licensing authority before the grant of manufacturing license by the authority.

Drug manufacturing in India:

The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030.
India is the world’s largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world.
Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.
According to Economic Survey 2023, the turnover in the domestic pharmaceutical market was estimated to be $41 billion.
India’s pharmaceutical exports revenue was $25.3 billion in fiscal year 2022–23, according to the data released by Pharmexcil.
India ranked third globally in terms of dollar value of drugs and medicines exports.
Major pharmaceutical hubs in India are: Vadodara, Ahmedabad, Ankleshwar, Vapi, Baddi, Sikkim, Kolkata, Visakhapatnam, Hyderabad, Bangalore, Chennai, Margao, Navi Mumbai, Mumbai, Pune, Aurangabad, Pithampur, and Paonta Sahib.

Source: TH