New Delhi: 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.
“Stability testing will be made compulsory for all the drugs. An advisory letter has already been sent to the state drug controllers and a notification amending the rules is likely to come soon," said G.N. Singh, drug controller general of India (DCGI).
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.
“We will also get random checks 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 licence," added Singh.
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.
The pharmaceutical industry is unhappy about the proposal to widen the ambit of the stability tests. “As of now the stability tests are carried out on formulations. If they widen the ambit and include all drugs, this will mean adding APIs and capsules too. It takes at least 6-9 months to carry out stability tests. There will be practical problems to get this done and we have been requesting the CDSCO to not include all the drugs into it," a pharma lobby group representative said on condition of anonymity.
Various stakeholders including pharma lobby groups, the Confederation of Indian Industry, the Federation of Pharmaceutical Entrepreneurs and the Organisation of Pharmaceutical Producers of India met CDSCO officials on 14 November, citing their problems.
CDSCO officials say they are unlikely to yield.
The Drug Consultative Committee, which comprises state drug regulators, had in November 2013 discussed the importance of stability data at a meeting and reached a consensus on the need to make stability testing compulsory.
“The members agreed that it is necessary that evidence and data of the stability of the drug products proposed to be manufactured by the licensee are required to be submitted to the regulatory authorities so as to ensure the stability of the drug formulations licensed in the country by the State Licensing Authorities," the panel had said then.