A total of 26 drug manufacturers from Punjab have jointly raised concerns over corruption by CDSCO officials and the pitfalls through a letter uploaded on the Portal for Public Grievances (PG Portal). Though the letter lauds the arrest of a CDSCO inspector by the CBI in Amritsar on 12.8.2019 and a Deputy Drugs Controller – India (DDC-I) in Delhi on 16.8.2019, they also inform that certain loopholes in regulations/policies or processes enable regulatory officials to misuse the power vested in them.
Citing the reasons why these malpractices continue to exist and thrive, they inform that the Drugs Act 1940 arms the inspector with discretionary powers (danda) to extort money. State inspectors are undeterred by the fact that the manufacturer approaches the state secretary/minister for redress whereas the union secretary/minister are beyond his reach. So, corruption by CDSCO/DCGI remains unchecked.
Oblivious of the facts, the central government brought several unconstitutional and illegal notifications like 1337 E at the behest of some CDSCO/DCGI officials to provide a danda to inspectors for extortion. Incidentally, the author of the said notification was none other than the DDC-I nabbed by CBI in Delhi.
Nabbing of CDSCO officials has not made much impact on other officials because manufacturers opposing CDSCO are victimised at ports at the time of import or export of consignments.
CDSCO inspectors claim that they have paid huge sums to get jobs which they have to recover.
Corruption by CDSCO/DCGI is nothing new. The 59th Report of Standing Committee on Health and FW on functioning of CDSCO exposed it conclusively in 2012, but no action was taken.
Highlighting how the reputation and future of the pharma industry in India is at stake, the letter states that the “only choice for a manufacturer has been to either pay bribe to CDSCO/DCGI or close down his business. Either way it is an insult to entrepreneurship which is the backbone of an economy.” The letter also cautions that unless systemic changes are enforced, corruption will continue under the prevalent conditions and such conditions are unaffordable to the economy. For instance, it suggests, “All notifications like 1337 E and 923 E, which empower CDSCO/DCGI illegally and unconstitutionally by wresting powers of the states in violation of Article 73/256 of the Constitution and Rule 18 of Drugs Act, may kindly be denotified.”
In very strong words, the manufacturers, through the letter, also recommend, “Every visit by inspector should be solely for the purpose of guidance to improve conditions and produce better-quality drugs instead of wielding a danda to extort money. In other words, the role of inspectors should be that of a facilitator and guide as in the west and not of an extortionist.”