Semaglutide – The Magical Injection
- It includes a medication known as semaglutide.
- This medication, which was initially prescribed to treat Type 2 diabetes mellitus, also causes weight loss.
- Although it is not authorised for sale in India, doctors are still giving it to largely wealthy patients.
Trials, clearance for sale in India:
- Typically, clinical trials are conducted by the Indian subsidiary or licensee of the global brand owner before drugs are licenced for sale in India.
- After approval, the regulator requires two years of monitoring and reporting of any unfavourable events.
- International pharmaceutical corporations may decide not to introduce new drugs into the Indian market.
- Under such conditions, anyone may obtain a licence from the drug regulator with a prescription from a physician in order to import these medications for their own use.
- Additionally, hospitals are able to apply for import licences.
- A medicine can only be sold in India after receiving approval from the drug regulator and passing clinical trial testing.
Problems with miracle medications:
- Clinical trials for unapproved “miracle drugs” have not been conducted in India.
- It’s unknown how the medication may affect Indians differently.
- Physicians in India won’t be able to predict how these injections will affect their patients who might be taking other medications for conditions like diabetes and hypertension—diseases that aren’t typically treated in developed nations.
An example of drug use without authorization:
- Counterfeit imported medications, such Adcetris, which is used to treat a particular kind of blood cancer.
- The WHO’s September 2023 warning about counterfeit medications prompted the pharma regulator to issue an alert.
- Due to the arrests made by the Mumbai police in October 2021, this alert was postponed by two years.
- It begs the question of how certain medical professionals are that the illegal import medications they are prescribing aren’t harmful knockoffs.
Required Licencing:
- It permits governments to provide licences to non-patent holders, or third parties, for the production and commercialization of patented goods and processes without the patent owners’ permission.
Applications for compulsory licences may be submitted at any point following the patent’s sealing date, provided that:
- The public’s reasonable requirements have not been met.
- A patented invention cannot be purchased by the general public for a reasonable amount of money.
- In India, patentable inventions are not practiced.
- The Indian Patent Act of 1970 regulates Compulsory Licencing.
- There is no explicit list of justifications for mandatory licencing in the TRIPS Agreement.
- The Doha Declaration on TRIPS and Public Health affirms that nations have the autonomy to define national emergencies and the conditions under which licences must be granted.
Evergreening:
- Just before an original patent expires after 20 years, corporations often file for an extension of the patent, making small changes to the product or procedure.
The Way Ahead:
- Before giving these medications, the doctors should be certain of their origin.
- According to the Supreme Court, the right to life is the most valuable human right and should be interpreted as such. It should be seen as the “ark of all other rights,” to be interpreted broadly and expansively in order to give it significance and vitality that will last for years to come and improve people’s sense of worth and dignity.
- “Enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being,” states the WHO Constitution.
