CDSCO releases regulatory guidelines for sampling of drugs, cosmetics & medical devices by drugs inspectors of central & state drug authorities. As per CDSCO, it will streamline and rationalize the sampling procedure of drugs, cosmetics & medical devices and maintain a centralized monthly database of Not of standard Quality (NSQ) or Spurious drugs to publish on CDSCO.
Good quality medicines are essential for efficient disease management. NSQ and Spurious drugs can cause treatment failure and adverse reactions, increase morbidity and mortality, and contribute to the development of drug resistance. Vulnerable populations and patients with co-morbidities are at particular risk of being harmed from receiving substandard or spurious medicines.
Drugs regulation in India is a complex process, where one side approval of new drugs, issuance of manufacturing license, wholesale license, retail license and their renewal/ retention are carried out by central and state regulatory authorities, which involves assessment of product technical documentation, inspection to ascertain manufacturers compliance with the principles of Good Manufacturing Practices (GMP) and approval or issuance of approval & license as per Drugs & Cosmetics Act and Rules there under.
Other side it also includes post-marketing surveillance (PMS) activities, such as maintenance of Market authorization/ registration through Post approval changes (PAC) for Biologicals, regular inspections of manufacturers, wholesalers and retailers, quality control testing, pharmacovigilance, routine sampling of products from the distribution channel and implementation of regulatory actions in the event of any quality problem reported to Drug Regulatory Authorities.
In general, sampling is carried out to assess the quality of drugs, cosmetics provided to patients and generate the data that can help to formulate strategies and plans to ensure the continuous availability of good quality products in the market. Sampling also confirms that patients are receiving satisfactory products and gives reassurance that the regulatory system of the country is functional, or when there is a suspicion that patients are not receiving satisfactory medicines.
The Section 22 & 23 of the Drugs & Cosmetics Act 1940 prescribes the detailed procedure for samples to be taken by Drugs Inspectors of Central and State drugs control as a part of routine drugs quality surveillance. Drugs sampling are costly task and limitations of resources may restrict the number of samples collected, parameters tested, techniques to be used for analysis or number of Drugs Inspector & Laboratory available to conduct the sampling and analysis respectively. Therefore, it is important to optimize the use of resources by focusing on parameters that pose a higher risk to patients and apply risk analysis during planning of the sampling.
From the past trends it is observed that there is no defined methodology for sample selection & location of sampling etc and was done randomly with the individual knowledge of Drug Inspectors. Often it was seen that sampled drugs are from big brands and collected from urban locations or sub urban locations only. The interior locations or rural distributions are not covered and thereby quality of drugs at distant user/ last users was not being assessed. Cosmetics samples were not collected in some regions. There is no centralize database of sale outlets where NSQ / Spurious product were reported, such identified outlets are to be kept for regular vigilance.
The main objective of the sampling is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications. This involves: Monitoring the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorised shelf-life; It will be useful for Ensuring that existing control methods are satisfactory; It will be easy to investigate the NSQ Product; Identifying Unapproved Products/ Without License sales outlets. Identifying Spurious drugs in the distribution chain; Identifying sales outlets where repetitive NSQ/ Spurious drugs are reported etc.
This guideline is mainly focused to utilize available information & identified risks for selection of sample & location to cover vast variety of drugs, cosmetic and medical devices moving in the market from manufacturing facility, wholesale outlet, retail outlet, government distribution channel etc. in urban, sub-urban, and rural locations. To maintain a centralized monthly NSQ/Spurious drug list and publishing on CDSCO website to avoid their further use.
This guideline will be useful for effective surveillance for quality & efficacy of drugs & cosmetic available in the market by adopting uniform drug sampling methodology for drugs inspectors under drug regulatory authorities of state and central.
