On August 7, the health ministry made changes in the New Drugs and Clinical Trial Rules, 2019. Now drugs approved in the US, the UK, Japan, Australia, Canada and European Union can be used in India without local clinical trials. This would make drugs manufactured outside India more accessible and affordable in the local market. The government has taken this decision to prevent delay in launching life-saving drugs in the country.
Before this, when any patented medicine was brought to India, clinical trials of that medicine were conducted here. It used to take about five to 20 years for the medicine to go through this process. Now if any new medicine gets approval in any six countries, it will be directly available in the Indian market as well.
This move is expected to encourage pharmaceutical companies to invest in research and development for new drugs in the country. It will also expedite the availability of life-saving drugs in India, particularly for patients with rare diseases.
The Central Drugs Standard Control Organisation (CDSCO) said that it will also evaluate demands for exemptions from clinical trials for novel medications designed for rare diseases, drugs needed during pandemics or for defense purposes and gene and cellular therapy products approved in established markets.
As per the Rule 101 of the New Drugs and Clinical Trial Rules, 2019, exemptions will be given only under five categories. These include expensive drugs prepared for rare diseases, gene and cellular therapy products, new drugs used in epidemic situations and for special security purposes and critical new drugs with medical advances.
As per officials, the most sought-after and latest medications that would help treat diseases like cancer and rare diseases such as Spinal Muscular Atrophy and Duchenne Muscular Dystrophy which are autoimmune conditions will become available expeditiously in India. Health ministry officials said this decision would save resources that were spent in the regulatory process of medicines and these could be used for some other work.
An order issued on August 7 by the Drug Controller General of India (DCGI) said: “As per Rule 101 of New Drugs and Clinical Trials Rules, 2019, the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules.
“In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely: USA, UK, Japan, Australia, Canada and EU are hereby specified for following categories of new drugs:
(1) Orphan Drugs for rare diseases.
(2) Gene and cellular therapy products.
(3) New drugs used in pandemic situation.
(4) New drugs used for special defense purpose.
(5) New Drugs having significant therapeutic advance over the current standard care.”
Clinical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and help improve health. These trials ensure that any medicine, surgical method, or, more broadly, an intervention is safe. At present, several medicines, already approved by other regulatory authorities in countries like the UK or the US are not easily available in India.
A new drug which is a modified form of a drug or Novel Drug Delivery System of any drug approved by the Central Licencing Authority (CLA) or a vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug shall continue to be a new drug forever. However, new drugs other than the above categories shall be considered new for a period of four years of their approval by the CLA.
A new drug means:
(i) A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, has not been approved as safe and efficacious by the CLA, i.e the DCG(I) with respect to its claims.
(ii) A drug approved by the CLA for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form.
(iii) A fixed dose combination of two or more drugs, approved by the CLA separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form.
(iv) A modified or sustained release form of a drug or novel drug delivery system of any drug approved by the CLA.
(v) A vaccine, r-DNA derived product, living modified organism, monoclonal antibody, stem cell derived product, gene therapeutic product or xenografts, intended to be used as a drug.
The office of the Drug Controller General grants approval of manufacture/import of new drugs for marketing in the country. This office is also responsible for granting permission to conduct clinical trials of new drugs including Investigational New Drugs. The Drug Controller General heads the Central Drugs Standard Control Organisation (CDSCO), which is responsible for approving licenses for certain categories of drugs.
There are six functioning central drug testing laboratories under CDSCO. The DCGI also establishes standards for the manufacturing, sales, import, and distribution of drugs in India and regulates medical and pharmaceutical devices. In case of any dispute with respect to the quality of the drug, the DCGI is the appellate authority.
—By Adarsh Kumar and India Legal Bureau