Get an Introduction to Pharmaceutical Legislations in India covering major drug laws, compliance, and regulatory frameworks affecting the pharma sector. Introduction to Pharmaceutical Legislations India’s pharmaceutical sector has developed over time due to growing healthcare needs and increasing industrial advancements. Before independence, the pharmaceutical industry in India was largely unregulated, and there was no proper … Read more
Below we have described about the key pricing mechanisms under DPCO 2013 and how they regulate drug prices in India to ensure affordability and compliance. Sale Prices of Bulk Drugs: Bulk drugs (active pharmaceutical ingredients) are the raw materials used to make medicines. Prices of bulk drugs can only be fixed or regulated by NPPA … Read more
What is National List of Essential Medicines? The National List of Essential Medicines (NLEM) is a list of medicines that are considered essential for public health. It is published by the Ministry of Health and Family Welfare and forms the basis of Schedule I of DPCO. Criteria for Inclusion in NLEM: Public Health Importance: Drugs … Read more
Introduction to Offences and Penalties under DPCO 2013 Below we have described the key offences and penalties under DPCO 2013 for drug pricing violations and non-compliance with Indian pharma regulations. Offences: Overcharging Beyond Ceiling Price: Selling a scheduled formulation at a price higher than the ceiling price. Failure to Display Price Lists: Manufacturers and retailers … Read more
Get an introduction to NPPA and its role in regulating drug prices ensuring availability and protecting consumer interests in India. The National Pharmaceutical Pricing Authority (NPPA) was established in 1997 by the Government of India under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Its main purpose is to control pharmaceutical drug prices, ensure … Read more
Drugs Price Control Order DPCO 2013 The Drugs Price Control Order (DPCO) was first introduced in 1970 and has been updated several times, with the latest version being the DPCO, 2013. Purpose of DPCO: It is a legal framework that regulates the prices of drugs in India. It specifically applies to drugs listed in the … Read more
This article talks about the key definitions in DPCO 2013 to understand important terms related to drug pricing regulation and pharmaceutical policies in India. Key Definitions in DPCO 2013 Scheduled Drug: A drug listed in Schedule I of DPCO, derived from the National List of Essential Medicines (NLEM). These drugs are subject to price control. … Read more
This article explains about the regulations for performance of experiments on animals ensuring ethical practices and compliance with animal welfare laws. Rules for Performance of Experiments: Approval by CPCSEA: No experiments should be performed without obtaining prior approval from CPCSEA or IAEC. Purpose of Experiment: Experiments must be conducted only if: a) Scientific Justification is … Read more
This article explains about the legal rules for transfer and acquisition of animals for experiments ensuring ethical sourcing and compliance with CPCSEA norms. Rules for Transfer and Acquisition of Animals for Experiments: Source of Animals: Animals must be obtained only from registered breeders or recognized institutions. Transfer Conditions: Animals must be transferred in safe, humane … Read more
Explore the offences and penalties in the Prevention of Cruelty to Animals Act 1960 for acts of cruelty neglect or illegal use of animals. Offences under the Act: Cruelty to Animals: Overloading, beating, torturing, or killing animals. Neglect or Abandonment: Failure to provide food, water, or shelter. Illegal Experiments: Performing experiments without CPCSEA approval. Transport … Read more
