India’s drug regulatory regime sucks. What now?

CDSCO’s Delhi HQ : Not all black and white

Not one person who has any claim to familiarity with India’s pharmaceuticals landscape can pretend to be surprised by the findings of a recent report on the functioning of CDSCO – India’s equivalent of the US FDA.

However, the report performs a very important task which is putting together recent facts and evidence in the public domain so that what was being discussed in dribs and drabs, from time to time, relying on dated statistics is now aggregated and more-or-less updated.

The report, put together by a Parliamentary Standing Committee attached to the ministry of healthy and family welfare, can be viewed here.

In a line, it shows how considerably unprepared India’s apex drugs regulatory body and its state-level counterparts are at safeguarding public health and safety.  Here are some key facts and statements :

1. Nine officers in the CDSCO’s headquarters handle 20,000 applications, sit in on over 200 meetings, attend to to 11,000 public/industry representatives, respond to 700 parliament questions, around 150 court cases etc each year. Over and above this, they also have sundry other duties such as deciding the fate of pharmacovigilance in the country or the essentiality of medicines.

2. India has 600,000 retail sales outlets and around 10,500 manufacturing units  (this data is still dated – vintage 2007), requiring over 3,200 Drugs Inspectors. However, there are only 846 Drugs Inspectors in place against 1,349 sanctioned posts in Indian states.

3. Drug regulation is a shared responsibility between the centre and the states.  But “there are serious shortcomings in centre-state coordination for implementation of the Drugs & Cosmetics Act and Rules,” the report finds. It adds that “no serious efforts seem to have been made”  in developing an effective system of coordination. Basically, the right hand doesn’t know what the left is doing – or doesn’t care.  (This was very obvious some years ago in the matter of irrational drug combinations. These were banned by the Centre but some states continued to approve them.)

4. There aren’t enough drug testing laboratories nor are they equipped to do their jobs well.

5.  Drugs are routinely approved on the basis of international clinical trials data without the mandated 100-subject safety and efficacy trial on Indian subjects. (This is for the purpose of throwing up any deviations in the drug’s safety and efficacy caused by racial/ethnic differences.   I have my views on whether even a 100-subject study serves the purpose when a drug has been tested on thousands of patients already. To be relevant it probably has to be larger, and more representative and followed up by rigorous post-marketing surveillance. But hey, rules are rules and so long as they exist they should be obeyed, right?)

6. Drugs banned in the US and major European countries are approved for sale in the country.

7. There is virtually no India-specific post-marketing follow-up so if  drug side-effects are unique to specific ethnic groups (which may not have been adequately represented in the clinical trials) these are unlikely to get noticed.

8. So-called independent experts or doctors who gave their views on specific medicines prior to approval seemed to have had their letters drafted by drug companies and merely signed off on them.

9. Currently, the academic requirement to qualify for the post of drugs regulator rules out plenty of good talent.

Basically anything that could go wrong has gone wrong.  Like I said, this isn’t terribly surprising.  For one,  public health and safety has never been a priority in this country. Think of the attitude towards safe drinking water or air safety (two ends of the technology spectrum, in a manner of speaking). So why should drugs be any different?

Of course, that does not mean we should stop taking our medicines.  Just as we don’t stop flying just because some Indian pilots have been known to get fake certificates, right?

Rather this development should be seen as a warning to set the house in order.

The next steps are pretty evident.

1. Get an enlightened and progressive health minister

2.  Ensure that the drugs regulator is unimpeachable whether on qualification or integrity

3.  Implement some of the solutions that the report contains such as ramping up infrastructure and manpower, involving independent medical experts from all over the country in consultations and so on.

4. Speedily investigate and take action against companies and officials who have broken the law or not followed rules. If some are legitimately cleared of blame, that can only be good news.

5. Balance out the industry influence by actively encouraging other stakeholders to participate. The drug industry currently exercises a great deal of  influence over the regulator’s office as various instances in the report, show.  While the office has been valiantly clearing thousands of applications in the face of manpower shortage, drug safety (which is not an industry priority) has historically been given short shrift. See my post here.

The influence can be evened out with greater participation from other stakeholders such as patient groups, civil society etc. CDSCO needs to go out of its way to include such groups (and please rational ones, not the rant-and-rave-sort).

6. Be transparent – so people know what you do, and how you do it publish everything that’s remotely worthy of being so on your website so. Nobody died of information overload.

7. Keep evaluating action taken and outcomes. Share this too.

Will I bet on this happening anytime soon? No, but that shouldn’t stop us from demanding.

In the meantime, here are some interesting remarks from the report

On the need for transparency : “In India, every discussion and document is confidential away from public scrutiny.”

On the geographical skew of medical experts that CDSCO consulted with : “One wonders whether expertise on drugs is confined to Delhi.”

On a health ministry official’s defence that most approvals in other countries are based on multinational clinical trials on various ethnic and racial groups as a reason to not do trials in India: “The interest is in those ethnicities that live in India, not Slavs, Caucasians, Hispanics and Negroes.”

And finally, the most damning, “Most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO. For decades together it has been according primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder i.e. the consumer has never been ensured.”

This last statement seems to have been provoked by the CDSCO’s mission statement  spelt out by the health ministry. I quote “to meet the aspirations…. demands and requirements of the pharmaceutical industry.” To this, I can only ask the ministry, “Guys, what were you thinking?”


5 thoughts on “India’s drug regulatory regime sucks. What now?

  1. Gauri, most of the drug regulatory authorities are overworked, understaffed and underpaid. Therefore corruption takes root in most of the FDA’s and FDA equivalent including the USFDA. Though i am certain things are not as bad as they are in India. I feel there is a pricing skew in India, now having lived in other developing countries, i feel Indian’ government and its authorities charge next to nothing and pay their people even less. If you go to even a country like Thailand, you realise that the working conditions of the staff are so so much better and of course they are paid very well. Especially the technical staff. Even non tech staff like drivers would be paid equavalent to Rs 30,000.

    I think till we address the fact that we have to pay for quality, we will never get out of the never ending cycle of having amongst the worst organisations. FDA becomes critical because of health care.


  2. Hey, have I read something similar like this before? Hmm, oh yes, it was about the state of the regulators in charge of Indian aviation!


  3. Gauri , very well compiled post . The need of the hour is infrastructure building with computerisation of the entire drug approval and monitoring process from the time a new drug application is received till approval including clinical trials and after approvals, monitor Advers Drug Reactions thru an effective pharmacovigilance program . Other countries have already implemented such systems and we can do it too without having to reinvent the wheel . it is impossible to effectively do all this manually . .


    1. Thanks. I’m getting the feeling that the health min’s investigation might end up centred around those few drugs that were approved without trials and do nothing about all the other problems that the report has highlighted. For instance, I do believe that at a stretch approving FDA or EMEA-approved drugs without India-specific trials should be alright so long as there is robust post-marketing surveillance done on them. Indeed, this should be de rigeur for all new drugs whether or not a 100-patient India study has been done on them. Yet we keep launching pvig programmes in the country without seeing them to their logical conclusion.


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