Mains Paper2 | Issues relating to development and management of Social Sector/Services relating to Health,
Prelims: Stability Testing, Drug Consultative Committee
Mains level: The news card talks about the recent proposed amendment by the India’s drug regulator in the Drugs and Cosmetics Rules, 1945, to make “stability testing” mandatory for all drugs sold in the country before they are deemed suitable for use by patients.
- India’s drug regulator is set to propose amendments to the existing Drugs and Cosmetics Rules, 1945, to make “stability testing” mandatory for all drugs sold in the country before they are deemed suitable for use by patients.
- Earlier in November 2013 the Drug Consultative Committee, which comprises state drug regulators, reached a consensus on the need to make stability testing compulsory.
What Impact the rules will have on Pharma Companies?
- Once the rules take effect, pharma companies will have to subject their products to quality tests to make sure that drugs do not lose their potency and the expiry dates printed on the packaging are based on the test results.
- Also random checks will be done from the samples picked up from the market and if any discrepancies are found, the companies will have to shell out fines and may lose their license.
- Mandated around the world, stability testing is the process of subjecting drugs to different tests in varying degrees of temperature and sunlight.
- In India, such tests are mandatory only for patented and proprietary drugs.
- The Central Drugs Standards Control Organisation (CDSCO) has proposed making stability tests compulsory for all drugs, including active pharmaceutical ingredients (APIs), the raw materials used in a drug that give it a therapeutic effect.
Views of Pharmaceutical Companies on the proposed rules
- The pharmaceutical industry is unhappy about the proposal to widen the ambit of the stability tests.
- Currently the stability tests are carried out on formulations.
- But widening the ambit of stability tests will usher in practical problems because it takes at least 6-9 months to carry out stability tests.
- And the pharmaceutical companies are requesting CDSCO to not include all the drugs into it.
- CDSCO officials say they are unlikely to yield.