Quick pill: On amendments to drug rules

The government’s move to scrap the traditional, mandatory test licences required to manufacture small quantities of drugs for research is an effort to remove the sometimes-crippling regulatory hurdles in the pharmaceutical sector. This decision aligns with the national goal of facilitating ease of doing business. The central element of these amendments to the New Drugs and Clinical Trials Rules, 2019, is replacing the mandatory licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism. Developers can now manufacture small quantities of drugs for research, testing, and analysis after intimating the Central Drugs Standard Control Organisation via its SUGAM Portal, online. Once a ‘notice of intent’ is acknowledged online, a company is free to go ahead with drug synthesis, strictly for research. In a post-COVID world, where speed of delivery for end use has gained virtue, the government anticipates that removal of this licencing factor will fast-track the timeline of drug development by at least three months. Specific low-risk bioavailability and bioequivalence studies can also commence after an online intimation on the portal. In addition, even for categories in which a licence is still required, such as for high-risk psychotropic or narcotic drugs, the statutory processing time will be reduced from 90 days to 45. All manufacturers are required to meticulously document and file processes as per rules.

The abolishment of a ‘licence raj’ is always good news. The dismantling of hurdles in pharma research and development bodes well for a country that is aspiring to position itself as the pharmacy of the world. The paperless, prior intimation mechanism will no doubt reduce the time spent twiddling thumbs, waiting for a physical copy of the licence. And time saved is, naturally, money and lives saved. Reducing the time a drug takes from the lab to the bedside for practical use can save countless lives and reduce morbidity in many more. However, the government would do well to circumvent the danger of a drop in quality control by initiating a mechanism, after intimation, to ensure that all good manufacturing practices are strictly adhered to. No drug, however speedily produced, is worth the blister it is packaged in if it comes with quality lapses. Poor pharmaceutical oversight, as recent cough syrup-related deaths showed, can be fatal.