A couple of days ago, the Economic Times (ET) reported quoting an anonymous source that the CDSCO would soon begin conducting surprise checks for compliance with regulatory standards at pharmaceutical manufacturing sites along the lines of inspections conducted by the USFDA. The anonymous source also told ET that “We may even issue suspension or cancellation of licences. In cases of major deviations, we may also (take legal action) against the company”.
Before we take such claims by the CDSCO at face-value, it may help to examine the CDSCO’s past track record in this area. Let us start with the Ranbaxy case. After I blew the whistle on Ranbaxy’s questionable manufacturing practices, the company agreed to pay damages and fines amounting to $500 million to the US Government for flouting cGMPs and selling adulterated medicine. The news of the fine caused quite the controversy in India including questions asked in the Parliament. While answering these questions, the then Minister for Health Ghulam Nabi Azad promised Parliament that the allegations against Ranbaxy would be probed. The Ministry of Health then wrote to the DCGI informing him that Ranbaxy had pled “guilty in the USA to charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy’s manufacturing facilities in India and that the Ranbaxy has been imposed a total of $500 million as fine”. As a result the Ministry ordered the DCGI to “review the GMP compliance of the above referred two manufacturing facilities of Ranbaxy in India as well as to ascertain the safety, quality and efficacy of drugs manufactured for the domestic market in these facilities, particularly during the period in question”. It has been almost three years since that order; the DCGI has not released any report regarding the results of such an investigation until now. Last year, my attorney filed a RTI application asking the DCGI for the status of the investigation – his office replied saying that the investigation was being carried out by the respective State Licensing Authorities (SLA) (presumably in the states of Himachal Pradesh & Madhya Pradesh) and that since investigation was still going on, the results of such investigation could not be shared. The following two points stand: first, the DCGI has conveniently shunted the job of investigation off to the state licensing authorities and second, the SLAs have not completed the investigation even after the fact that Ranbaxy has admitted to wrongdoing in the USA. How can it take so long to investigate a case where the company in question has basically admitted to all charges? Moreover, I have never been contacted by the DCGI despite being the person with the most detailed understanding of what exactly went wrong at Ranbaxy. What is even worse is that when my attorney subsequently filed a RTI with the Health ministry asking whether the DCGI had been given permission to outsource the investigation to state authorities – the Health Ministry replied in a negative. We also asked the Health Ministry whether at a minimum, whether Ranbaxy to explain the circumstances leading up to the fine imposed in the US – the answer was negative. So there you have it; two of the largest pharmaceutical manufacturing plants which have been banned from exporting products to the USA continue to supply the Indian market with drugs of questionable quality of drugs with nobody from the Indian regulatory establishment bothered to even ask the company which paid such a large fine to explain what exactly went wrong. What does this tell your about accountability at CDSCO?
After news of the Ranbaxy pleading guilty to seven counts of criminal felony in the USA, the DCGI sent a circular to all SLAs informing them to instruct all licensees within their jurisdiction that information regarding adverse foreign regulatory action was required to be shared with the all SLAs, who were then required to share such information with the DCGI’s office so that “its impact in Indian scenario can be assessed and necessary action is taken to ascertain the quality, safety and efficacy of the drugs available in the country.” My attorney filed RTI applications to test the effectiveness of implementation of this circular. We picked two cases where foreign regulators had flagged Indian manufacturing plants for flouting regulatory laws. The first was a case from Vietnam – where the Vietnamese drug regulatory agency had blacklisted a total of 46 India based pharmaceutical manufacturers. It is unfortunate that there was very little coverage of this issue in the India media. The Indian Consul General in Vietnam, Deepak Mittal wrote to the Indian Government requesting an investigation against these companies so that the Indian mission in Vietnam could assure the local authorities in that India was committed to be a reliable supplier to quality medicines. When the DCGI was asked via a RTI application the status of these investigations, his office once again denied providing information on the grounds that the State Licensing Authorities (SLAs) were still in the process of carrying out investigations (2 years after the Vietnamese had blacklisted these companies) and that information could not be shared as it would jeopardise the investigations. In the second case, we asked the DCGI whether they had followed up on the reasons behind the ‘import bans’ that were imposed by Health Canada on the Indian manufacturing plants of Apotex Pharmachem India Pvt. Ltd, Apotex Research Pvt. Ltd. and IPCA Laboratories. These plants are located in Madhya Pradesh and Karnataka. (RTI Application enclosed) The reply from the DCGI’s office clearly washes its hands off the matter entirely and places it at the doorstep of the SLAs in Madhya Pradesh and Karnataka – the reply states “Licences are issued by the State Licensing Authorities and inspections are conducted periodically. CDSCO headquarters has not conducted any inspection with respect to the alleged ban imposed by Health Canada.”
The common thread in all of the cases that I’ve discussed above is the fact that the CDSCO has constantly palmed off the job of investigations to the state licensing authorities. In none of these cases has CDSCO seriously investigated the offences. Given this track record, I find it difficult to believe CDSCO’s claim that it is going to conduct ‘surprise checks’. It just seems like an empty threat. Why not start with cases where foreign regulators have already found cGMP violations? At least, their inspection reports give CDSCO a starting point for its supposed investigations.
Further, the quote by the CDSCO threatening to cancel or suspend licences isn’t entirely substantiated in law because as per Rule 69 and its associated rules (of the Drugs & Cosmetics Rules, 1945), only the State Licensing Authorities can issue manufacturing licences for drugs. The only manufacturing licences that the Central Government can issue are for ‘new drugs’ under Rule 122B and under Rule 68A for the manufacture of medical devices such as cardiac stents, drug eluding stents, catheters, bone cements, heart valves etc. The new drug status lasts for 4 years after which the CDSCO loses jurisdiction over these drugs. Thereafter, it is the states that regulate manufacturing and only the state licensing authorities can cancel these manufacturing licences. Even presuming that a CDSCO team does find violations during the first 4 year period, it can cancel the licence only for the particular drug in question – the remaining drugs licensed by the SLAs can still be manufactured at the same facility until such time that the SLA in governing that manufacturing facility suspends or cancels the licence issued to the facility. To put it politely, it is an absurd state of regulation.
No wonder that Judge Endlaw of the Delhi High Court has reportedly quipped in the recent litigation regarding the banning of FDCs by the central government “It appears that since you do not have power to control your state licensing authorities, you are taking this action. It all boils down to this that you have exercised this power as you do not have power to take action against those operating without valid license from the Drugs Controller General of India (DCGI)”.
It is however important to note that while the CDSCO has limited, almost no, powers to cancel licences, it does have substantial powers under Section 21 to draw samples, inspect plants and launch prosecutions in cases where central government laboratories have declared the drug to be NSQ. We have a list prosecutions launched by the CDSCO (West Zone) available here. As demonstrated by the Tamil Nadu drug inspectors in the Alfred Berg & Co case, it is also possible to prosecute these companies for GMP violations in criminal court. From what we have seen from all our resarch, it doesn’t appear that the CDSCO is prosecuting many cases. Doesn’t this tell us how serious the CDSCO is about ensuring our drug supply? If it really wants to crack the whip, the CDSCO should prosecute manufacturers of NSQ drugs in states like Himachal Pradesh and Uttarakhand which are the fountainhead of the sub-standard drugs in India. The proof is in the pudding, and forgive me for not taking this empty threat from the CDSCO seriously. The CDSCO is a toothless tiger; often hand-in-glove with the industry and choosing to look away rather than being accountable to the people of India. Its threat to suspend licenses and take legal action against wrongdoers rings hollow.
I had anticipated the complexity and the push-back that we see from the industry on a small slice of the problem area, Fixed Dose Combinations. My PILs were the best option to wipe the slate clean and start with a robust, accountable and transparent legal framework that produced a globally consistent regulatory framework. Unfortunately, the highest court in the land thought this was an academic exercise; it is not. It affects the health of over a billion people who live in India.