Himachal: Pharma companies to adopt WHO norms

Ambika Sharma

Solan, January 7

In a move aimed at ensuring quality production of drugs, pharmaceutical companies having an annual turnover of over Rs 250 crore will have to adopt revised good manufacturing practices (GMPs) within six months while the small and medium manufacturers have been given a year’s time to adopt the same.

MSMEs seek more time

• The small and medium manufacturers have been given a year’s time to adopt the adopt revised good manufacturing practices but they are seeking extension of the time
• Rajesh Gupta, president, HDMA, said: “The government should extend the timeline for the MSMEs to three years as the requisite modifications will require an overhaul of the operational units involving big investment”
• Majority of the MSMEs were already reeling under the liability of loans and availing additional loans would be time consuming. The association fears it will lead to closure of several small units

Erring units to invite penalty

• Those failing to comply with the modifications, which will bring the units on a par with the World Health Organisation’s standards, will face suspension of their licence or a penalty
• The norms have been implemented after notification of the revised Schedule M of the Drugs and Cosmetics Act on December 28 by the Ministry of Health and Family Welfare

The latter have, however, sought extension of the time given the investment involved and their current debt liabilities. Those failing to comply with the modifications, which will bring the units on par with the World Health Organisation’s standards, will face suspension of their licence or a penalty. The norms have been implemented after notification of the revised Schedule M of the Drugs and Cosmetics Act on December 28 by the Ministry of Health and Family Welfare.

The step aims to tighten the noose around drug manufacturers after several deaths were reported abroad due to consumption of spurious drugs.

The Himachal Drug Manufacturers Association (HDMA), while sharing the government’s concern on ensuring quality drugs manufacturing, said it would be a major challenge for the micro, small and medium enterprises (MSMEs) to incorporate the slew of changes in a running unit within a year.

Rajesh Gupta, president, HDMA, said: “The government should extend the timeline for the MSMEs to three years as the requisite modifications will require an overhaul of the operational units involving an investment ranging from Rs 2 crore to Rs 5 crore.”

He added that majority of the MSMEs were already reeling under the liability of loans and availing additional loans would be time-consuming. The association fears it will lead to closure of several small units. The industry also resented that though the ministry had adopted global standards while amending the Schedule M, instead of introducing guidelines they have incorporated a rule making it a more stringent provision.

The manufacturers will be required to incorporate major changes like introducing pharmaceutical quality system, quality risk management, product quality review, qualification and validation of equipment, change control management, self-inspection and quality audit team, suppliers audit and approval, stability studies as per recommended climate condition, validation of GMP-related computerised system, etc.,

Issues like inappropriate documentation, which included improper record of testing of drug batches, lack of maintenance of the machinery, including its timely validation, non-functional air handling units and dysfunctional lab equipment, lack of self-assessment, absence of internal product quality review, faulty designs of manufacturing and testing, etc. have been raised by the drug regulators in the risk-based assessments.

As many as 60 pharmaceutical units, including eight labs, have been issued stop-manufacturing orders either fully or partially or of certain products in the three phases of risk-based joint inspections conducted so far.

Deputy Drugs Controller Manish Kapoor said they would seek data of all pharmaceutical units to ascertain their compliance within the stipulated time period.

There are about 650 pharmaceutical units in the state with at least 70 per cent being MSME. More than 200 of them are approved by WHO and the USFDA. Every third medicine sold nationally is manufactured in Himachal.