Regulatory clean-up

The World Health Organisation’s alert to the Gambia and other countries to take off the shelves cough syrups manufactured by a Haryana-based company is a moment of reckoning for the Indian pharmaceutical sector. At stake is the industry’s standing as a global competitor. The days of a lazy, unexacting, soft stance on drug regulation and in dealing with offenders are over. Only a rigorous nationwide drug-testing regimen can salvage India’s reputation as the pharmacy of the world, which ensures that even the poorest are able to afford its drugs. Going by the journalistic accounts of grossly ill-equipped testing laboratories, chronic understaffing and lack of effective deterrents, a whole lot of ground is to be covered.

The regulatory system faces huge challenges. State drug controllers rarely communicate with each other or apply the law uniformly. Quality is overlooked in the overzealousness of states to outbid each other in promoting the industry. Red flags are ignored. Poor training and antiquated record-keeping add to the malaise. The grant of manufacturing licences can be arbitrary; standards are not adhered to. The pharmaceutical industry cannot absolve itself of a large share of the blame. It forgets that ignoring the slightest of regulatory failures in maintaining the prescribed good practices can cost lives. By not acting against or disciplining the rogue players, it fails every patient.

The death of several children below five years of age in Jammu and Kashmir in 2020, attributed by alert PGI doctors to an adulterated cough syrup manufactured by a Himachal Pradesh unit, should have sparked national outrage and resulted in major changes, but, sadly, it did not. The Gambian tragedy is a wake-up call like no other. There is no escaping a complete clean-up of the regulatory framework, including penal action. In most cases involving the supply of substandard drugs, the only punishment meted out is suspension of the firm’s licence to manufacture the drug for a few days. It’s a cruel joke.