India Revises Regulatory Guidelines for Sampling of Cosmetics and Other Regulated Products

On May 26, 2026, India's CDSCO released revised Regulatory Guidelines for Sampling of Drugs, Cosmetics and Medical Devices by Drug Inspectors of Central and State Drug Authorities, introducing enhanced reporting requirements to strengthen post-market surveillance and regulatory enforcement. The document supersedes the original version issued in February 2024, which has been in effect for several years to standardize sampling practices across India.

The revised guidelines largely retains the structure of the 2024 version, covering sampling plans, sample selection, sampling location selection, sample numbers, sample quantities, timelines, database and monitoring, Not of Standard Quality (NSQ) and spurious alerts, as well as testing laboratories.

The key revision lies in the introduction of more detailed reporting requirements for products identified as NSQ or spurious. Under the updated framework, the monthly NSQ reporting format now requires drug inspectors to specify the following: product type, product name, brand name, dosage form, route, NSQ Keyword, manufacturer name, manufacturing state, details of the firm where it has been manufactured by, manufacturing date, expiry date, reporting source, reporting month and year, batch number, NSQ result, and modified dosage form (if applicable). This represents a significant expansion from the existing format, which only required basic information such as product and drug name, batch number, manufacturing and expiry dates, manufacturer name, NSQ result, and the details of the CDSCO or state laboratory that reported the result.

For the cosmetics sector, sampling requirements remain unchanged. The guidelines continue to specify sample quantities for 18 cosmetic categories, including skin creams, shampoos, hair dyes, lipsticks, nail polishes, and kajal. For example, inspectors are required to collect three 50 g packs of skin cream and fifteen packs of lipstick for laboratory testing.