- Prelims: Miracle drug, Type 2 diabetes mellitus, magic injection, Adcetris, Cancer drugs, standing committee on health, WHO, CDK etc
- Mains GS Paper II: Science and technology- developments and their applications and effects in everyday life, biotechnology and issues related to IPR etc
ARTICLE HIGHLIGHTS
- The press releases by global pharma companies advising patients not to use magic injections that guarantee weight loss in India do not get any publicity in the media.
INSIGHTS ON THE ISSUE
Context
Magic injection:
- It contains a drug called Semaglutide.
- It is Originally used for the treatment of Type 2 diabetes mellitus, this drug also results in weight loss.
- It has not been approved for sale in India but is being administered by doctors to patients who are mostly affluent.
Trials, sale approval in India:
● Drugs are normally approved for sale in India only after the Indian subsidiary or licensee of the global brand owner conducts clinical trials.
● Once approved, the regulator mandates monitoring and reporting all adverse events for two years.
● Global pharma companies sometimes choose to stay out of the Indian market and not launch drugs in India.
○ In such circumstances, patients can get a license from the drug regulator based on a doctor’s prescription to import these drugs for personal use.
○ Hospitals too can apply for import licenses.
● Drug needs to be tested in clinical trials in India and is available for sale only after approval by the drug regulator.
Issues with miracle drugs:
- Unapproved “miracle drugs”: there have been no clinical trials in India.
- It’s not known if Indians will react differently to the drug.
- Doctors in India will be unable to know how patients who may be taking other drugs for ailments such as diabetes and hypertension in India (that are not prescribed in most developed countries), will react to these injections.
Case of using drugs without approval:
- Spurious imported drugs such as Adcetris, a drug used to treat a type of blood cancer.
- The drug regulator only issued an alert regarding spurious drugs after the WHO issued in September 2023
- This alert was delayed by two years as the arrests made by the Mumbai police in October 2021
- It raises the question of how sure doctors are that the unapproved imported drugs they are administering are not dangerous fakes.
Compulsory Licensing:
● It allows governments to license third parties (that is, parties other than the patent holders) to produce and market a patented product or process without the consent of patent owners.
● Any time after three years from date of sealing of a patent, application for compulsory license can be made, provided:
1. Reasonable requirements of the public have not been satisfied.
2. Patented invention is not available to public at a reasonably affordable price
3. Patented inventions are not carried out in India.
● Compulsory Licencing is regulated under the Indian Patent Act, 1970.
● The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing.
● Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licenses, and to determine what constitutes a national emergency.
Evergreening:
● It is the practice of companies filing for an extension of a patent with minor process or product modifications just before the original patent expires at the end of 20 years.
Way Forward
- The doctors should be sure of the provenance of these drugs before administering them.
- The Supreme Court has interpreted right to life as the most precious human right:“ark of all other rights must be interpreted in a broad and expansive spirit so as to invest it with significance and vitality which may endure for years to come and enhance the dignity of the individual and the worth of the human person”.
- According to the WHO Constitution: “enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being”.
QUESTION FOR PRACTICE
How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies?(UPSC 2019) (200 WORDS, 10 MARKS)
