Nine pharma units shut ops in Kangra, blame 'inspector raj', US-aligned norms for closures

Medium, small and micro pharmaceutical industries in Kangra district are staring at a crisis. At least nine such units have closed and several others are on the brink of shutdown. Industry players warn that if corrective steps are not taken, the fallout can cripple the state’s drug manufacturing base and lead to a shortage of essential medicines in the country.

The owners of the affected units squarely blame the 'inspector raj' and the sudden enforcement of the revised Schedule M norms, which are aligned with US standards, for the crisis. They argue that the compliance requirements are impractical for micro and small pharma firms to meet within the limited time frame.

In Nurpur, four of the seven units have already shut operations while five factories in Sansarpur Terrace, once a bustling hub of 15 factories, have closed down, leaving over 700 workers jobless. The factories that have shut operations are Medox Unit 1, Medox Unit Injectable, Abaris Health Care, Rachil Remedies and Dixon Pharma. Six more units are reportedly on the verge of closure.

Industry associations allege that anonymous complaints filed by middlemen often trigger regulatory crackdowns. The same intermediaries later offer contracts for the upgrade of factories and obtaining WHO certification at the cost of crores of rupees.

The pharmaceutical manufacturers also claim that they are forced to pay between Rs 3 lakh and Rs 10 lakh every year as “protection money” to avoid harassment, particularly in Kangra and Una districts. These units have demanded a three-year grace period for the upgrade of their facilities, a 10-year compliance road map, subsidised loans of Rs 10 crore per unit and an inquiry into the alleged nexus between brokers and regulatory officials.

The additional requirements such as bio-availability and bio-equivalence (BA/BE) studies, which cost about Rs 30 lakh per product, are also hitting small players hard. The manufacturers say that the rules favour large pharma houses, pushing micro and small enterprises into a crisis.

The Himachal Pradesh Drug Manufacturers Association has stated that the ‘inspector raj’ is spreading fear in the sector. “This is not ease of doing business,” it warns. It adds that nearly 400 units in Himachal Pradesh may shut down if no relief is provided. Around 2,000 workers in Kangra district alone are at the risk of losing their jobs.

The association states that micro, small and medium firms contribute nearly 40 per cent of India’s drug production. Their collapse can lead to medicine prices skyrocketing and an acute shortages of drugs nationwide.

700 workers rendered jobless

• In Nurpur, four of the seven units have already shut operations while five factories in Sansarpur Terrace, once a bustling hub of 15 firms, have closed down, rendering over 700 workers jobless