One of the most shocking discoveries during the course of my research into the Indian drug regulatory system over the last few years were the minutes of the 46th meeting of the Drugs Consultative Committee (DCC) held in 2013, which has representation from all the state drug control administrations. These minutes revealed that stability testing was compulsory for only those classified as ‘patent and proprietary’ drugs. Stability testing according to the minutes of the committee was not mandatory for the generics approved by state licensing authorities. In pertinent part, the minutes noted the following:
“Since there is no requirement as a condition of license 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.”
At the time I was shocked to read this because stability tests are mandatory across the world for all medicines whether generic or patented. The simple aim of a stability test is to ensure that medicine can retain its efficacy despite changing temperatures and pressure conditions. Some of this testing is done soon as the batch is manufactured while some of the testing is done after a few months on samples of the batch that have been retained. If a batch fails stability testing it has to be recalled and destroyed. Manufacturers obviously do not like to lose money like this but then again, they should perhaps invest in quality manufacturing.
Stability testing is especially important in a country like India with its hot and humid climate which can cause poorly manufactured medicine to break down chemically. There are simple techniques to test the stability of these drugs such as putting the medicine in a controlled temperature and pressure environment to examine its durability. Of course, these tests take up time and resources. During my time at Ranbaxy I had discovered that the company was regularly fudging stability data for the American market.
At the DCC meeting in 2013, the committee had made the following recommendation to the government to make stability testing mandatory for all generics:
“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 licenced in the country by the State Licensing Authorities. The DCC after deliberation agreed to the proposed amendments to the Drugs and Cosmetics Rules, 1945.”
As of 2016, when I filed a PIL before the Supreme Court, the recommendation of the DCC had not yet been enforced which is why I made it an issue in the PIL. After the Supreme Court’s reluctance to admit my PIL, I sent a report to the Health Ministry outlining several issues, including the need to make stability testing mandatory. On May 2, 2017 the Ministry of Health published draft rules for making stability testing compulsory for generic medicine. However, for some reason, the draft rules were never translated into law and a few months later, in August, the DCGI was sending plaintive letters to state drug controllers requesting them to “advise” manufacturers to submit stability data. At the time I co-wrote an op-ed in the Indian Express shaming the government for its failure to make stability testing mandatory despite a consensus that such testing was required. Finally, in April, 2018 the Ministry of Health made stability testing mandatory by amending the D&C Rules.
The battle however was only half won because the industry has been fighting back tooth and nail. On February 11, 2019 the business portal Pharmabiz reported that the pharmaceutical industry had sought the rollback of mandatory stability testing for generic medicines. The report quotes an industry official as saying the following:
“This is indeed a big challenge for existing as well as new manufacturers and becomes a hurdle for implementing the mission “Make in India” to invite new plant, will badly affect the export and unit in the pharmaceutical sector. Because due to this it shall take minimum 8 to 9 months to finish stability test and get product approval of molecules for commercial production for the new as well as existing manufacturing units, a delay which shall put a huge financial burden,” said Nipun Jain, chairman of SMPMA.”
This statement basically accepts that the Indian industry has been exporting pharmaceutical drugs to several jurisdictions (presumably countries with lax regulatory requirements, called ROW countries) without complying with the standards of mandatory testing. I am simply stunned at the callousness with which the Indian industry puts its own profits before the well being of its patients.
It gets worse. Last month, Pharmabiz reported that the drug manufacturers in Bihar approached the DCGI to complain against the state drug controller on account of its anti-industry policy. The main grouse against the Bihar drug controller was the fact that he sought to apply the mandatory stability testing requirement! The Pharmabiz article cites some outdated guidelines from 1988 without any reference to the amendment to the amendments in 2018 that made stability testing mandatory. The same article reveals an incredibly hostile attitude of the local manufacturers towards the regulator in Bihar and it is clear that the industry is trying to have him “administratively reassigned”.
In light of these news reports, I strongly suspect that the mandatory stability requirements are not being enforced by most the state drug controllers. A guidance document that was to be released to guide state drug controllers and industry on the parameters of stability testing is pending despite a committee being setup specifically for this task. The minutes of the DCC can be viewed here.
In this regard, I have written to the Health Secretary Ms. Preeti Sudan, requesting that she ask the DCGI to submit a report on the implementation of the mandatory stability testing by state authorities as well as urgently release the guidance document for public comment so that all stakeholders can contribute to defining the stability requirements for our drug supply. Given the pushback from the industry, I fear that the industry will attempt to hijack the process behind closed doors. Further, a guidance document on this issue would help state drug controllers in implementing the stability requirement with consistency across the country.
The letter to Secretary Sudan can be found here.