What is meant by generic drugs? Explain its importance in the light of judicial decisions in India.

Question

In its second preliminary objection, Myanmar submits that The Gambia’s Application is inadmissible because The Gambia lacks standing to bring this case before the Court. In particular, Myanmar considers that only “injured States”, which Myanmar defines as States “adversely affected by an internationally wrongful act”, have standing to present a claim before the Court. In Myanmar’s view, The Gambia is not an “injured State” (a term that Myanmar appears to use interchangeably with the term “specially affected State”) and has failed to demonstrate an individual legal interest. Therefore, according to Myanmar, The Gambia lacks standing under Article IX of the Genocide Convention.
Myanmar draws a distinction between the right to invoke State responsibility under general international law and standing before the Court. It argues that, even if it were established that a “non-injured” Contracting Party to the Genocide Convention has the right to invoke another State’s responsibility for violations of the Convention, this would not necessarily entail the right to bring a case before the Court. To this end, Myanmar contends that there exists a difference between the common interest in the accomplishment of the purposes of the Genocide Convention and a State’s individual legal interest that may be enforce through the institution of proceedings before the Court. In Myanmar’s view, only States “specially affected” by an internationally wrongful act have standing to bring a claim before the Court.
Myanmar further submits that The Gambia’s claims are inadmissible in so far as they are not brought before the Court in accordance with the rule concerning the nationality of claims which, according to Myanmar, is reflected in Article 44 (a) of the International Law Commission’s Articles on the Responsibility of States for Internationally Wrongful Acts. Myanmar asserts that the rule concerning the nationality of claims applies to the invocation of responsibility by both “injured” and “non injured” States and irrespective of whether the obligation breached is an erga omnes partes or erga omnes obligation. Consequently, in Myanmar’s view, The Gambia lacks standing to invoke Myanmar’s responsibility.

Answer 1

Definition first:
A generic drug matches a brand-name drug in active ingredient, dose, and effect, and is sold under its chemical name once it clears regulatory approval. Since the original innovator has already proved the molecule safe and effective, the generic maker's only real burden is proving bioequivalence, so approval is faster and cheaper, and that saving is what gets passed on as a lower price.

Checkpoint one, regulatory control:
The Drugs and Cosmetics Act, 1940, and the CDSCO decide whether any drug, generic or branded, can be manufactured and sold in India, so a cheaper price never comes at the cost of an unverified drug. This is the baseline safety check that applies regardless of what happens in patent law.

Checkpoint two, stopping weak patents:
Section 3(d) of the Patents Act, 1970, refuses a patent on a minor variation of a known drug unless it is shown to work meaningfully better. The Supreme Court applied this in the Glivec case to deny Novartis a patent on a new crystal form of an existing cancer drug, which is the single biggest reason Indian generic versions of that drug could keep being sold.

Checkpoint three, overriding a valid patent when needed:
Even a properly granted patent can be opened up through a compulsory licence under Section 84 if the drug is priced beyond what patients can reasonably afford. This was used for the cancer drug Nexavar, letting Natco Pharma sell a generic version at a much lower price while still paying royalty to the patent holder.

Why this matters for access:
Together, these three checkpoints mean price is never assumed to be untouchable in Indian drug law, healthcare affordability is treated as a real interest that limits how far patent protection can go, which is why India stayed a major source of low-cost generic medicine even as global drug prices for the same molecules stayed high.

What is meant by generic drugs? Explain its importance in the light of judicial decisions in India.

Solution and Explanation

Top Questions on Public International Law

Questions Asked in CLAT PG exam