A plethora of government bodies are there in the country to ensure legal compliance and punish those who don’t abide by the rules & regulations. However, are they really working the way they are supposed to? For nearly every punishment, both real or imagined, there is a legitimate and unofficial price to pay. The legitimate route is expensive, is prone to various hassles, paperwork heavy, and dependent on frequently non-functioning institutions/devices – while the unofficial route is cheap, quick, and forgettable. As incompetence and corruption make India’s roads some of the most inefficient & chaotic – so does incompetence & corruption in making Indian drug quality dubious.

The typical Indian forgets bribes quickly, but they remember each of the instances they attempted to follow the law. The bribe is quick, while the processes are confusing/drawn out. The guardians of the law, the various state and central drug-authorities frequently disregard all instances of the law in order to accrue as much income as possible. This makes following the law in order to receive licenses a mind-numbing activity. You will not get your license unless you pay money or get political support.

Through discussions with various politicians and administrative officers, some of whom have been Ministers of Health & Drug Controllers, we have discovered the following points:

• Corruption in drug quality begins the politician in charge. If they are corrupt, then the lower-level bureaucrats get the courage to be corrupt.
• When districts are being allocated, the corrupt minister places the most corrupt/hard-working lower-level bureaucrat in the busiest areas to extract the maximum “revenue”.
• Lazier/honest bureaucrats are relegated to lower impact areas.
• The bribes that are paid are split and paid throughout the entire hierarchy.
• This means that it is useless to complain to anyone within the hierarchy. In fact, complaints will be held against you.
• If ‘lobbying’ such that bribes do not have to be paid, you must approach someone outside the hierarchy who can hold them accountable.
• Someone above or besides the entire hierarchy

This system of licensing gives undue power to certain bureaucrats who by the very whim of their minister, must misuse it in order to acquire money. The following are the various reasons such a system is detrimental to drug quality.

Moral Authority

Drug regulators lose any sense of doing things for the “greater good” the moment they require bribes. If the guardians are corrupt, why should those they guard be any better?

Regulatory Necessity

If drug regulators view licenses as permissions that are given in exchange of monetary gain, then “Regulation” goes out the window. Companies that otherwise would have complied with regulation had regulation mattered, now do not bother to. The regulator cares if you pay them, not whether you comply – why comply?

Coherence of Law

The current Drugs & Cosmetics Act was created before Indian Independence. Various state acts have been passed, but they frequently contain arbitrary and nonsensical provisions – what exactly is a pacca roof? You care about a fridge when most medicine do not require it, but not an air conditioner? Why must the size of a retail store be 110 square feet? The same square footage requirement exists for distributors?

If these laws were followed with, then individuals & regulators would start to care, and perhaps we would come to more sensible rules & regulations. Perhaps there would even be a turnaround time for license applications instead of letting them sit idly for months until either pressure is applied or application lubricated. But if arbitrary rules help confuse potential applicants to make thwarting their application easy, then why should anyone care about whether the law makes sense?

Presence of Law

Drug Inspectors in India, frequently do not know the law, nor do they practise it. The law becomes secondary to the system that they accept. For example, a much-touted law is that Retail Drug Licenses have a limit to the amount of income they can declare. There is no such law, but many drug inspectors insist this is real. Similarly, many norms have been created by this cadre that have no real basis in reality, and are instead used to extract income from the weak.

Manufacturing License Dilution

Attaining a manufacturing license, license to manufacture certain drugs, WHO-GMP certification, and so-forth all lose their meaning if the reason these licenses were granted were due to a bribe. There is a reason that bribe-free United States FDA giving approval to facilities means something more to the stock market than any Indian Drug Regulatory authority ever could.

Excess Cost on Manufacturer/Distributor/Retailer

The manufacturer not only has to worry about supply, demand, operations, and competition – they also have to worry whether they have enough money for the latest demands that have come from local corrupt bureaucrats. These costs are added into the price of your medicine, but the regulation/corruption isn’t improving quality one iota.

Conclusion

With no moral authority, lack of understanding of the importance of regulation, and lack of coherence and presence of law – what do you think happens if a drug inspector one day actually stumbles upon spurious or substandard medicine? They ask for a bribe of course – it is what they have been conditioned to do.

Don’t believe me? Look at the following article: Click here

What happened to this case? Does anyone know? Since it is within the hierarchy, well the entire hierarchy could be corrupt and they all might have taken a cut – so we will never hear from this again.

Drug Regulation in India as it currently stands increases costs and stress to manufacturers and retailers with no discernible quality impacts.

Perhaps it does do one thing, inefficient manufacturers/distributors/retailers, cannot survive the constant requests for cash and probably bow out. So, if someone is mass producing low-quality medicine, they better be doing it in bulk, and making enough cash to pay off all that come asking. That or they better have some good political connections.