The drug policy in India had been framed and the rules had been formulated under the Drugs and Cosmetics Act, 1945, which aimed to provide essential pharmaceutical products at reasonable prices, and facilitate original produce at cost-effective prices without a compromise on quality, while also facilitating export of pharmaceuticals by reducing trade barriers. This drug regulatory system exists at both central and state levels, whose authority lies in the hands of the Central Drugs Standard Control Organization (CDSCO), headed by the Drug Controller General of India (DCGI). In addition, the Food & Drug Administration (FDA) regulates the manufacture, distribution, and sale of drugs, while controlling the quality of food articles.
Amendments made over the years
With all of these authorities in action, various amendments have been made in the Drugs and Cosmetics Act, 1945 from time to time, in order to regulate the manufacture, distribution, sale, and import of drugs depending upon the current requirements.
- In 1985, illicit trafficking of narcotic and psychotropic substances was controlled with The Narcotic Drugs and Psychotropic Substances Act.
- In 1995, the prices of drugs were controlled with The Drugs Prices Control Order.
- In 2014, several amendments were made keeping in mind the pain management required for cancer patients.
- In 2015, medicines were included along with dosages and strengths under the National List of Essential Medicines.
- In January 2019, the menace of drug addiction was controlled with the J&K drug de-addiction policy.
The latest amendments made
The Union Health Ministry has also modified the Act to lay down rules for new drugs, clinical trials, bioavailability, bioequivalence, and ethics committees. The new rules have promoted research at local levels, and eased regulations for new drugs. Some of the most important amended points include –
- Ease of experimental study – Rules have been framed to provide waiver for experimental study of new drugs already studied, approved, and marketed outside India for more than two years, provided that the Central Licensing Authority is satisfied.
- Trial waiver for drugs researched outside – New drugs developed outside India with no serious adverse effects, may be waived for local clinical trials, and approved for use in India.
- A quick process – It generally took lots of time to get approval for clinical trials from the DCGI (almost 180 days). But now, the time for approval has been limited to 90 days, after which if there is no response, the approval is taken as having been granted.
- Appeal opportunity for sponsors – Sponsors have the authority to appeal for reconsideration of the DCGI decision, but the participant has no authority of the same. While earlier, free medical management was provided up till it was established that any injury wasn’t related to the clinical trial, now the rules have changed to “as per the opinion of the investigator”.
With such amendments made, clinical trials have now become easier and quicker for being executed in India. This has brought in more and more sponsors to take interest in clinical research in India, after a break of five long years, which is for the betterment of the country’s medical segment. Thus, the Indian medical industry is all set to boost up, which means if you take up clinical research as a career, you are sure to have a bright future. And, when you settle on this decision, Avigna Clinical Research Institute’s clinical research diploma courses in Bangalore can help, where you can receive authorized education from recognized professors, and receive a legitimate certificate to climb the ladder towards clinical success.
