Something on Drug Manufacturer norms :
Now let’s do some deep dive.
How paraphrasing and misleading argument of CDSCO and the Indian drug industry have used for years: that only “adulterated” and “spurious” can cause bodily harm, but that “Not of Standard Quality (NSQ)” drugs can’t
D&C Act defines adulterated, spurious and NSQ drugs. To begin with, the definitions in the D&C act are pretty badly worded, and therefore, vague. So, let me tell you how CDSCO and state regulators interpret these definitions
Essentially, an adulterated drug is one into which some “noxious” substance has entered. So, when diethylene glycol (DEG) enters cough syrup, killing kids, regulators will prosecute manufacturers under Section 27(a). That’s good, because, of course, DEG causes bodily harm.
The definition of a spurious drug is pretty flexible among regulators. Some will prosecute a drug with 0% active ingredient as a spurious drug (section 27(c)). Spurious literally means a drug pretending to be something it’s not – a fake or a counterfeit.
Yet others will prosecute someone making a drug without a licence as spurious. Because such manufacturers may use labels of other companies. So, again, this is a fake drug or a counterfeit.
Obviously, criminal prosecution is welcome in the case of spurious drugs too. These, too, will cause bodily harm, after all. So far, so good
What has changed with the Jan Vishwas bill, which
@d_s_thakur pointed out, is that, from now on, the manufacturers of Not of Standard Quality (NSQ) drugs can pay money to escape jail terms.
Simply put, an NSQ drugs is a drug that does not meet the minimum legal standards mandated in our country. So, if your antibiotic ciprofloxacin, which you might be taking for some horrible respiratory or stomach infection, has only 50% of ciprofloxacin, that’s an NSQ drug .
Your tablet could have ciprofloxacin content as low as 25% or 15%, and it would still be classified as an NSQ drug (has been, historically), not an adulterated or spurious drug.
Let’s take injections: Suppose you got a steroid injection while you are grievously ill, and admitted into an ICU. Now, suppose this steroid injection was contaminated with bacteria, and that killed you (which it easily could), that injection would be an NSQ drug.
Now, let’s say this albendazole does not dissolve in your body (a dissolution test is a minimum legal standard for albendazole in India). This means it won’t be effective against worms. Now if a child takes this and gets anemic, the albendazole would be classified as NSQ.
However the MoHFW claim is that NSQ drugs cause you no bodily harm. And that the only drugs that cause bodily harm are adulterated or spurious drugs.
Hope it helped you understand the current nomenclature in drug safety protocols.