Explainer: Why Himachal’s pharma sector is facing a trust crisis

ACCLAIMED as Asia’s pharmaceutical hub with 651 small and big firms, Himachal Pradesh accounts for every third drug in the domestic market and 35 per cent of the national output. Its trust and credibility quotient, however, is under strain as in the last three years, 1.39 per cent of the drug samples drawn by the state drug authorities have failed quality parameters.

The state Health and Family Welfare Department informed the Vidhan Sabha recently that of the 12,034 drug samples drawn for testing, 168 were declared ‘not of standard quality’ (NSQ). These comprised cough syrups, injections, vitamin supplements, eye drops and injections, besides drugs used to treat cancer and common ailments.

Additionally, a large number of substandard drugs figure prominently in the monthly alerts issued by the Central Drugs Standard Control Organisation (CDSCO). Some firms habitually appear in this list for multiple violations month after month.

The usual suspects

Drug samples often default on parameters like inappropriate assay content, which compromises the drug’s efficacy, leading to serious health implications. Vital factors like dissolution or disintegration tests are also found breached. Since these measure how quickly a tablet or capsule breaks down and releases the active ingredient for absorption by the body, failure means the drug might not be absorbed properly, rendering it ineffective.

What is particularly worrisome is the presence of particulate matter in injections, considered a serious, high-risk defect which can manifest soon after being injected. Substandard injections prominently figure in the CDSCO list every month.

Other quality parameters like improper pH levels, content uniformity issues, misbranding, and sterility issues also contribute to NSQ drugs.

Stringent measures

In order to assess the regulatory compliance of drug manufacturing units, the Central drugs regulator CDSCO, in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022. The measure was aimed at identifying chinks in the manufacturing protocols.

“A slew of deficiencies have been exposed in the manufacturing units during such inspections as greed takes primacy over quality. Issues like non-functional air handling units, dysfunctional equipment in micro labs, besides lack of validation and calibration of the machinery expose the lack of apt maintenance,” says a pharma expert, not wishing to be named.

He attributes these inadequacies to a lack of testing and adherence to quality control protocols. “An aptly maintained manufacturing facility will deliver quality drugs,” he asserts.

While the authorities have been taking punitive action against erring units, some continue to churn out substandard drugs habitually.

“Forty firms have faced legal action in the last three years while administrative action, including suspension of product licence, was initiated in 52 cases for a few months. Two firms also faced licence cancellation while some challenged the test reports,” says State Drugs Controller Dr Manish Kapoor.

In a bid to bring manufacturing on a par with the global World Health Organisation norms, all drug firms have to upgrade their facilities to the revised Schedule M by December-end. Officials feel this will rein in the erring manufacturers, though only 116 of them have opted for it since it was introduced in January 2023.

Pharma sector’s defence

Dr Rajesh Gupta, president of the Himachal Drug Manufacturers Association, says the figures do not tell the complete story. “Against the national average of 2.64 per cent ‘not of standard quality’ drugs, barely 1.39 per cent drugs suffered from this inadequacy in the state,” he says. The authorities should also share the figures of drugs adhering to quality standards as this is a much bigger number, Gupta argues.

He says the NSQ drugs are ‘out of specification’ as per the global terminology and do not run the risk of proving to be fatal like some cough syrups manufactured in several states. “These defects can be removed by addressing the manufacturing deficiencies. Nearly 250 units have adopted the World Health Organisations’s good manufacturing practices to deliver quality drugs.”

According to Gupta, “1.39 per cent is a miniscule number vis-a-vis the quantum of drugs manufactured in Himachal”, while calling for stricter action against habitual defaulters like cough syrup manufacturers.

Reining in offenders

The State Drugs Controller says strict adherence to laws is the only answer. “The reasons behind the lapses are thoroughly investigated to take corrective steps. Stricter measures like re-sampling, factory inspections, quality audits and risk-based inspections have been initiated for repeat offenders to identify systemic failures and enforce corrective actions,” says Dr Kapoor.

He also alleges attempts to tarnish Himachal Pradesh’s pharma sector as 20 drug formulations with fake manufacturing addresses in Solan and Sirmaur districts have been confiscated from six other states — Uttar Pradesh, Gujarat, Madhya Pradesh, Karnataka, Telangana and Haryana — this year.

HUB OF ACTIVITY

Number of pharma units in Himachal:651

Clusters: Baddi-Barotiwala-Nalagarh, Kala Amb, Paonta Sahib, Parwanoo, Mehatpur, Solan, Sansarpur Terrace

Key players: Cipla, Dr Reddy’s Laboratories, Torrent Pharmaceutical, Sun Pharmaceutical, Glenmark Pharmaceuticals, Alkem Laboratories, Lupin Limited, Zydus Lifesciences