A few weeks ago, the Drug Controller General of India (DCGI) issued a circular to all state drug regulators “requesting” them to “advise” manufacturers to “submit stability data”. The positively servile language of the circular could have possibly been ignored if the same circular did not say “Stability of drug is of paramount importance to ensure quality, safety and efficacy of the drugs throughout its shelf life”. Why then, one may ask, is the country’s top regulator not seeking an amendment to the Drugs & Cosmetics Rules, 1945, to make stability studies compulsory for all drugs rather than requesting state regulators to “advise” drug manufacturers to submit such data?
Stability testing is perhaps one of the most important quality tests mandated for drugs around the world. It entails putting manufactured drugs through a series of stress tests that involve subjecting the drugs to varying temperatures, sunlight, etc. The aim of these tests is to ensure that the drugs do not lose their potency after they get shipped out into the market where storage conditions will greatly vary during the supply chain. While certain drugs will always need refrigeration, most drugs are expected to meet certain specific quality standards wherein they remain stable even in a hot and humid climate as is found in several parts of India. Stability testing ensures the drugs are stable in conditions expected in the Indian climate. If the drugs are not stable, they can lose their potency even due to slight atmospheric changes and this change will not be obvious to the patient. Most importantly, patients will have the confidence that the dates of expiry printed on the packaging are based on actual test results, not some arbitrary date that the company uses to sell its products.
Currently, in India, stability testing is compulsory only for those “new drugs” that are regulated by the DCGI. Once a drug loses its “new drug” status after 4 years, any new manufacturing applications are handled by the state regulators and the law currently does not require them to compulsorily require stability data. The Drug Consultative Committee (DCC), which has different state drug regulators as its members, had discussed the importance of stability data at its 46th meeting held in November 2013.
The agenda for the meeting stated: “Since there is no requirement as a condition of licence of proving that drugs are stable under recommended conditions of storage for other than Patent & Proprietary Medicine in Drugs & Cosmetics rules, it can lead to unstable products being licensed in the country. As it is serious lacuna, it is very important to put it in rules.”
The minutes of the meeting which discussed the agenda indicate that there was consensus on the proposal to amend the rules to make stability testing compulsory.
The relevant extract from the minutes reads as follows: “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 DCC after deliberation agreed to the proposed amendments to the Drugs and Cosmetics Rules 1945.”
Now, 4 years later, the DCGI is making servile requests to the state regulators to “advise” drug manufacturers to submit stability data, rather than writing to the Ministry of Health requesting them to amend the rules to make sure that stability testing is made mandatory.
It is also important to note in this context that falsified stability data was one the primary reason why Ranbaxy was penalised by the US.
Investigation by the US FDA Office of Criminal Investigation conclusively proved that the company supplied “fabricated” stability test data to secure market authorisations for its product in the US. Since 2007, there have been numerous citations, for lack of stability data, to Indian pharmaceutical companies issued by the US FDA. Even domestically, stability has for long been a major problem with Indian drugs during random testing by Indian drug regulators. Every time a drug fails stability testing during random sampling by state regulators, our drug manufacturers palm off the blame on poor storage conditions at the pharmacy.
If the law is amended to make stability testing compulsory and if our drug manufacturers can resist the urge to fabricate or manipulate data, we may actually improve the quality of drugs made available to Indian patients.
For this to happen, the DCGI and the Ministry of Health & Family Welfare will have to get their act together and amend the Drugs & Cosmetics Rules, 1945. Earlier this year, the Ministry of Health did amend the rules to make bioequivalence testing compulsory. However, the joint secretary who signed off on that notification was shipped out of the ministry shortly thereafter. What is holding the Ministry of Health back from making stability testing compulsory when the DCC has unanimously agreed on the need to make such ‘stability testing’ compulsory through an amendment to the rules? Does its allegiance to the industry rise above public health?
Currently, testing is mandatory for ‘new drugs’ only
Stability testing is perhaps one of the most important quality tests mandated for drugs around the world. It entails putting manufactured drugs through a series of stress tests that involve subjecting the drugs to varying temperatures, sunlight, etc
Currently, in India, stability testing is compulsory only for those “new drugs” that are regulated by the DCGI. Once a drug loses its “new drug” status after 4 years, any new manufacturing applications are handled by the state regulators and the law currently does not require them to compulsorily require stability data