One of the most significant failings of the Indian drug regulatory system is its failure to put in place a mechanism to recall NSQ drugs from the market. Such recalls may be necessitated either by post-marketing surveillance or alternatively due to internal review of manufacturing processes within the pharmaceutical companies. For example, statistical quality control on a series of batch records may indicate trends which are not easily recognizable on single batch records. Likewise, long term stability studies may reveal that a particular batch degrades quicker than what is printed on the label. In such cases, a robust and traceable process to account for all commercial product present in the market so that it can be returned and destroyed is a key component of the regulatory oversight.

Indian pharma companies regularly conduct drug recalls in the US and EU. In the recent past, there have been several cases of large pharmaceutical companies like Sun Pharma, Dr. Reddy’s and Wockhardt recalling, hundreds if not thousands of units of their drugs from the American market. However, I have never seen similar drug recalls being affected in the Indian market. The key reason why we do not see such action in India is because the Indian drug regulatory law does not have a legal framework mandating such recalls. Every time a drug is declared NSQ by a government analyst, there is no legal requirement under the law for the manufacturer to initiate a nation-wide recall and there is no procedure to monitor such recalls. The futility of the Indian system was pointed out in the 59^th Standing Committee report when it noted:

“15.5 By the time a sample is tested, a large number of packs get sold out with undeterminable injury to patients. There is no effective method of recalling unsold stocks lying in the distribution network. This cannot be allowed to go on.”

At the time of this report, the Committee was pushing for more transparency – in particular it wanted publication of the NSQ drugs in newspapers. I extract the relevant paragraphs below:

“15.11 The Committee recommends that once a batch of a drug is found to be substandard and reported to CDSCO, it should issue a press release forthwith and even insert paid advertisements in the newspapers apart from uploading the information on the CDSCO website. Retail chemists should be advised to stop selling unsold stocks and return the same to local Drugs Inspectors as per rules. The Committee understands that at least two State Drug Authorities, that of Maharashtra and Kerala, have taken the initiative to upload information on spurious and sub-standard drugs on their websites on a monthly basis. These are welcome measures worth emulating by other states and the Centre.”

The Committee’s singular focus on this issue helped in creating the current ‘Drug alert’ system wherein the CDSCO publishes information on its website about drugs declared NSQ in central government laboratories. Such a system is pretty useless unless integrated with the state government labs, since the states are the ones which conduct a lion’s share of testing. Currently, some state regulators from states like Gujarat and Maharashtra do make available the most recent NSQ data on the XLN website. Very few people, even within the industry, know of this website. The Standing Committee was very cognizant of these limitations, especially the consequence of only the CDSCO making information available on its websites. In its 66^th report had pertinently stated:

“3.195 The Committee notes that to begin with CDSCO has started the drug alert system in respect of drugs found to be not of standard quality, spurious, adulterated, etc. by central drug testing laboratories. Furthermore, the Ministry is considering the feasibility of placing advertisements of such cases regularly in the newspapers. The Committee is convinced that this is a herculean task, which can be achieved only when the efforts of the Centre and State Governments are fully synergized. Drug alerts of evaluations by central drug laboratories though welcome would not take care of this acute problem in entirety as the state drug laboratories handle major volumes of such evaluations. The Committee, therefore, desires the Ministry to take up this matter with State Governments on a highly proactive basis to ensure its early fructification. It also desires early decision by the Ministry on utilizing newspapers in this task.”

Some state regulators do send such information to newspapers which publish the information in small columns in their city editions, but this information is of little use given the level of inter-state commerce of drugs in India; a batch declared NSQ in Maharashtra may have also been partially sold to other states. The only way to fix this system is to have a nationwide recall system implemented and monitored rigorously by the CDSCO. In quite a coincidence, at about the same time that the 59^th Report pointed out this issue to the government, the World Health Organisation (WHO) had raised the same red flag during its National Regulatory Assessment (NRA) of the CDSCO. As a result the CDSCO published for the very first time Draft Guidelines on Recall of Drugs. While some websites like RAPS have reported that the Guidelines are now in effect, we have not found any evidence to substantiate this claim. We do know for a matter of a fact that the draft guidelines were published on the internet for comments and were subsequently discussed at the 45^th and 46^th meetings of the Drugs Consultative Committee (DCC), held in February, 2013 and November, 2013. However, neither the public information officers in the CDSCO nor the state drug regulators seem to be aware of these guidelines when my attorney filed RTI applications with each of these authorities asking them whether they follow any particular recall guidelines.

In a RTI application filed on April 15, 2015 we asked the CDSCO the following questions:

“(i) Does the CDSCO have in place a mechanism to issue a safety alert or a product recall on the basis of a test report from a State Drug Controller which indicates that a product is not of standard quality?

(ii) Please provide copies of all such orders issuing safety alerts or product recalls in the last 2 years.

(iii) Are State Drug Controllers mandated to intimate the CDSCO every time they detect a drug which is not of standard quality? Please provide all such intimations received by the CDSCO in the last 2 years.”

The reply we received from the CDSCO can be accessed over here. There isn’t even a squeak about the Draft Guidelines.

In June 2015, we filed a second set of RTI applications where we asked the CDSCO the following questions (only the first is relevant):

“(i) Please provide the applicant with a copy of the guidelines or rules laid down by the CDSCO in order to issue “Drug Alerts” or “Recalls”.

(ii) Please provide the applicant with details of the action taken with regard to the ‘Drug Alerts’ issued by the CDSCO in April, 2014 i.e. does the CDSCO also prosecute the manufacturer? (Printout from CDSCO website enclosed herewith as Annexure A).”

The response, which can be accessed here is completely silent on the guidelines and speaks only of recalls.

We then repeated this exercise with a series of state drug regulators asking them the following two questions:

“(1) Does the Controller follow any specific rules or guidelines to recall a drug that is detected as being of ‘Not of Standard Quality’. Please provide the applicant with a copy of such rules of guidelines.

(2) What is the procedure followed by the Controller while deciding appropriate legal action when a sample is detected to be of ‘Not of Standard Quality’. Does the Controller initiate criminal prosecution in all cases or is suspension of licences enough. The PIO is requested to please provide the applicant with a copy of procedure/rules to be followed while deciding appropriate legal action in such cases.”

The responses from Maharashtra, Andhra Pradesh, Tamil Nadu, Karnataka, Uttarakhand & Himachal Pradesh are available in the legal section of this blog site. Each state gave us different answers – while HP and Karnataka refer to the DCC Guidelines referred to in my previous post, others like Maharashtra claim that recalls are governed by the Drugs & Cosmetics Act – both answers are wrong. The DCC guidelines don’t mention anything about drug recall and the D&C Act doesn’t deal with drug recalls. The authority in Tamil Nadu responded claiming that recalls were dealt with under Schedule M to the D&C Act – this schedule contains the GMP code and under which all manufacturers are required to have a recall system in place but such a system is very different from a mandatory drug recall system where a regulator supervises a nation-wide recall. Other countries like the USA, the UK, have a specific legal framework to govern such recalls. The only state which appears to have a rudimentary system in place is Andhra Pradesh. That state regulatory agency has some rules that mandate information sharing with all drug inspectors. However state-wise regulatory mechanisms are completely useless in India since drugs can flow across borders seamlessly – the only solution is a centralised recall procedure.

It was quite surprising for us to discover that none of the states are aware of the CDSCO’s draft guidelines. One of the PILs that I had filed had raised this issue – in fact this was the very first prayer sought for. Specifically, I had asked the Supreme Court to issue a writ to create binding rules on drug recalls. The reason for asking for such a prayer was because the draft CDSCO guidelines on recall lack the force of law behind them. There is no provision in the D&C Act empowering the CDSCO to draft guidelines. Delegated legislation is supposed to be enacted in the form of rules or regulations – the CDSCO however failed to cast these recall guidelines as rules. On the other hand the national regulator for food safety, the FSSAI, had long ago published specific regulations on recall of food which can be accessed here. The drug recall guidelines should have been drafted in a similar fashion, as rules or regulations rather than as filmsy guidelines.

It is interesting to compare the recall statistics of Indian pharama companies in the US to what they do in India. The US FDA provides information about product recalls and withdrawls in a transparent manner. One can search for the names of Indian pharma companies in this database to see how often and how many recalls have they issued in the US. Assuming the same competence and compliance in their manufacturing process for India, which we know is a false assumption, nevertheless, we ought to see a similar number of recalls of their product in our country as well. Comparing these statistics from the US to what these same companies do in India answers the question of what a legally binding, robust and effective recall procedure does for public health in India.

The enactment of a mandatory recall mechanism would have been a game-changer in the Indian context because the number of alerts generated by each state would have forced a wider debate on the reason behind such recalls. The biggest challenge we face in addressing this problem of substandard drugs is public awareness about their prevalence and outcomes from their use. A wider national debate about consolidated recalls across states would have raised this issue prominently in the media and public eye. Unfortunately, the Supreme Court thinks this is an academic issue and refused to hear my petition.