Product Compliance


The CDSCO risk assessment is a process used by the Central Drugs Standard Control Organization (CDSCO) in India to evaluate the safety and efficacy of drugs, cosmetics, and medical devices. The CDSCO is responsible for ensuring that these products are safe and effective for the Indian population.

The Risk Assessment Process Involves a Number of Steps

  • Identifying the hazards: This involves identifying all of the potential risks associated with the product, such as side effects, adverse events, and contraindications.
  • Assessing the risks: This involves evaluating the likelihood and severity of each hazard.
  • Developing risk mitigation strategies: This involves developing strategies to minimize the risks, such as labeling changes, warnings, or restrictions on use.
  • Monitoring the risks: This involves monitoring the product for safety concerns after it has been approved for use..

Benefits of The CDSCO:

  • Protects public health : The CDSCO’s primary function is to protect public health by ensuring that only safe and effective drugs and medical devices are available in India. It does this by setting standards for drugs and medical devices, conducting clinical trials, and monitoring the safety of drugs and medical devices after they have been approved.
  • Improves access to safe and effective drugs : The CDSCO’s work helps to improve access to safe and effective drugs for all Indians. By ensuring that only safe and effective drugs are available, the CDSCO helps to reduce the risk of adverse reactions and other health problems.
  • Boosts the Indian pharmaceutical industry : The CDSCO’s work also helps to boost the Indian pharmaceutical industry. By providing a clear and efficient regulatory framework, the CDSCO makes it easier for Indian pharmaceutical companies to develop and market new drugs.
  • Creates a level playing field : The CDSCO’s work helps to create a level playing field for all pharmaceutical companies operating in India. By setting the same standards for all companies, the CDSCO helps to ensure that all drugs are of the same quality, regardless of who makes them.
  • Provides transparency and accountability : The CDSCO is committed to transparency and accountability. It makes all of its decisions public and provides a mechanism for stakeholders to appeal its decisions.