The Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies is a major move in the direction of bolstering India’s rules for next-generation drugs. The amendment provides a specific approach to advanced therapy medicinal products (ATMPs) such as gene and cell therapies, tissue-engineered products, and ART, but a combination of two. Cutting-edge treatments provided here provide welcome hope for patients with rare genetic conditions and disorders, cancers and chronic diseases.
The government is aiming to incentivise innovation better while ensuring patient safety, product quality and ethical standards through updating the Drugs Rules, 1945. In this regard, India is likely to be better equipped to develop, test, manufacture and market high-tech biological drugs once the Drugs Rules are amended by the Central Government of India.
What are Advanced Therapy Medicinal Products (ATMPs)?
Based on the changes made in the Drugs Rules, 1945, by the Ministry of Health and Family Welfare (MoHFW), Government of India, under the amended rules.
- Advanced Therapy Medicinal Products (ATMPs) are innovative medicinal products with a novel biological technology that are applied for the treatment, prevention or diagnosis of a disease.
- They consist of Gene Therapy Products (GTPs) – which are used to modify or replace genes to treat inherited or acquired diseases.
- Cell Therapy Products (CTPs) are living human cells that have been significantly processed, altered or would have a different essential function when administered to the recipient.
- Tissue-Engineered Products (TEPs) are engineered cells or tissues that will regenerate, repair, or replace human tissue.
- The new rules also include Combined ATMPs, which contain one or more medical devices and one ATMP.
- ATMPs are regulated under a specific framework in India for ensuring quality, safety, efficacy and ethical aspects before use in a clinical trial and marketing.
PYQs Related to Advanced Therapy Medicinal Products – Drugs Rules
| Year | Exam | Question | Options | Answer |
| 2023 | UPSC Prelims | With reference to mRNA vaccines, consider the following statements: 1. They use messenger RNA to instruct cells to produce a specific protein. 2. They alter the recipient’s DNA permanently. Which of the statements given above is/are correct? | (A) 1 only (B) 2 only (C) Both 1 and 2 (D) Neither 1 nor 2 | (A) 1 only |
| 2022 | UPSC Prelims | Which one of the following techniques allows scientists to edit genes with high precision? | (A) ELISA (B) PCR (C) CRISPR-Cas9 (D) Electrophoresis | (C) CRISPR-Cas9 |
| 2021 | UPSC Prelims | Which one of the following enzymes is primarily used to amplify DNA in the Polymerase Chain Reaction (PCR)? | (A) DNA Ligase (B) Taq DNA Polymerase (C) Restriction Endonuclease (D) Reverse Transcriptase | (B) Taq DNA Polymerase |
| 2020 | UPSC Prelims | Which of the following are applications of stem cells? 1. Regeneration of damaged tissues 2. Treatment of certain blood disorders 3. Drug testing and research | (A) 1 only (B) 1 and 2 only (C) 2 and 3 only (D) 1, 2 and 3 | (D) 1, 2 and 3 |
| 2019 | UPSC Prelims | Which one of the following is NOT a component of recombinant DNA technology? | (A) Restriction Enzymes (B) DNA Ligase (C) Ribosomes (D) Cloning Vectors | (C) Ribosomes |
| 2018 | UPSC Prelims | Which branch of biotechnology focuses on repairing or replacing damaged tissues and organs? | (A) Tissue Engineering (B) Nanotechnology (C) Fermentation Technology (D) Immunology | (A) Tissue Engineering |
| 2017 | UPSC Prelims | Consider the following statements regarding stem cells: 1. They can self-renew. 2. They can differentiate into specialised cell types. Which of the statements given above is/are correct? | (A) 1 only (B) 2 only (C) Both 1 and 2 (D) Neither 1 nor 2 | (C) Both 1 and 2 |
| 2016 | UPSC Prelims | Which one of the following diseases has been treated using gene therapy in clinical research? | (A) Haemophilia (B) Sickle Cell Disease (C) Severe Combined Immunodeficiency (SCID) (D) All of the above | (D) All of the above |
| 2015 | UPSC Prelims | Which of the following best describes regenerative medicine? | (A) Development of antibiotics (B) Repair, replacement or regeneration of cells, tissues and organs (C) Manufacture of vaccines only (D) Food preservation | (B) Repair, replacement or regeneration of cells, tissues and organs |
| 2013 | UPSC Prelims | Which of the following biological products are classified as Advanced Therapy Medicinal Products (ATMPs) in modern medicine? | (A) Gene Therapy Products (B) Cell Therapy Products (C) Tissue-Engineered Products (D) All of the above | (D) All of the above |
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Conclusion on Drugs Rules, 1945, amended by Centre
Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies is a significant reform in the healthcare industry of India. The amendment takes forward a specific system for Advanced Therapy Medicinal Products, fostering innovation whilst maintaining safety, quality and ethical benefits. This reform equips India to become a more active member of the biotechnology and precision medicine chain, as technology advances. Ultimately, the Centre Amends Drugs Rules, 1945 to Regulate Advanced Therapies lays the foundation for safer, more effective, and innovative healthcare solutions.
