From Flawed Data Entries to No Pest Control & More: Inside Details of Probe Into Kala Amb-Based Pharma Firm

Reported By: Himani Chandna | Source: News18.com

According to the joint investigation report, the manufacturing facilities for potent drugs such as sex hormones and beta-lactam are common with general drug category products. The inspectors also found that the incoming materials were not always purchased from approved vendors

Unusual microbe growth, data integrity issues, missing pest control agreements, mixed-up manufacturing areas and more — the inspection at Himachal Pradesh-based Pushkar Pharmaceuticals in India’s ongoing inspection drive at pharmaceutical firms has revealed more than 30 major and three critical lapses.

The manufacturer of capsules, injections, and sex hormones has been found to produce potent drugs, including critical antibiotics, in a shared facility with general pharmaceutical products. This situation poses a potential risk of cross-contamination or mixing up of products.

In snapshot, according to the investigation report accessed by News18, the critical and major observations include “having common manufacturing facilities for potent drugs such as hormones, beta-lactam along with the general section, issues of data integrity, failure of microbiological samples, failure to produce water validation reports, not monitoring the environmental control periodically, validation studies incomplete and not conclusive, data not recorded contemporaneously, audit trails not available…”

The investigation is conducted jointly by inspectors sent by the Delhi-based headquarters of the country’s apex drug regulatory agency Central Drug Standard Control Organisation (CDSCO) along with inspectors from the Baddi-based unit of CDSCO and inspectors from the officer of Himachal Pradesh’s drug regulator.

Pushkar Pharmaceuticals is one of the many drug units situated in Himachal Pradesh’s drug-making hub which is currently under scanner for violations of medicine safety standards. It is home to 71 pharmaceutical firms of India’s 209 firms which are shortlisted for risk-based inspections by the central government and CDSCO.

The company manufactures eye, ear and nasal drops along with the small-volume parenteral (SVP) category. These preparations are generally sterile solutions or suspensions packaged in vials, ampoules, or prefilled syringes.

It also manufactures a critical product range, including the Beta-lactam category, which includes antibiotics that are among the most commonly prescribed drugs. It also manufactures sex hormonal categories, including oxytocin, testosterone and Hydroxyprogesterone caproate, which are used for fertility treatments, during pregnancy or childbirth.

News18 reached out to the company multiple times via e-mail and on their WhatsApp number given on the website. However, no response was received till the time of publishing the news report.

According to the company’s website, “In Kala Amb, there is a lot of hormonal injectables manufacturer in Himachal. But the thing that makes us different from others is our service and quality. Pushkar Pharma is the best pharmaceuticals manufacturing company, the best injectables manufacturer situated in the state of Himachal Pradesh. The company is fully equipped with ultra-modern and sophisticated equipment.”

BOTCHED-UP RECORDS, MISSING AGREEMENTS, CRITICAL LAPSES

According to the joint investigation report, the manufacturing facilities for potent drugs such as sex hormones and beta-lactam are common with general drug category products.

“The main entry to the premises which leads to the hormonal section, beta-lactam section and general category drugs products section is common,” it said.

“The firm is using the same sampling and dispensing area for the hormonal products and general category drugs products…without having a proper supply of filtered air and without having suitable measures for dust control to avoid contamination. These rooms were not found under differential pressure.”

It also said that the firm failed to produce an agreement with an outside pest control agency when asked to “Describe the pest, insects, birds and rodents control system followed in the premises” as part of the necessary checklist.

The investigators also found another crucial lapse. “During the round to the microbiological section wherein the environmental monitoring (EM) settle plates for aseptic areas have been incubated… and it was observed that microbial growth was observed for all these plates which was found to be more than specified limits,” said the report (sic).

Under the section “Specify whether pure steam (condensate) used in production meets the microbiological specification…, the reply was “not being tested”.

The inspectors also found that the incoming materials were not always purchased from approved vendors.

“During the visit to the raw material store, it was observed that the Lignocaine HCL IP API was supplied by the M/s Xylo Chem Industries. However, the under list of approved vendors the M/s Xylo Chem Industries was not available,” it said, while sharing other examples too.

The report also said the production area was not found ‘adequately lit’. Also, safety goggles (by the staff) were not being used in the critical manufacturing areas.

Moreover, under the category of “How records of complaint and adverse reactions are maintained”, investigators found that the “Firm has not maintained the log book for market complaint”.

The firm, the report said, “has not provided the qualification reports for major manufacturing equipments of injectable lines”.

CDSCO’S LOCAL UNIT ADVISES ACTION

Concluding the 69-page risk-based joint inspection report, Baddi-based CDSCO has directed Himachal Pradesh’s state drug controller to take action against the firm.

“As from the GMP checklist and benchmarking, it is concluded that the firm is grossly deficient in meeting the requirements of Schedule M under Drug Rules 1945.”

Deputy drug controller Chandrashekar Ranga, from the state unit of CDSCO, has advised the state regulator to direct the firm “to stop production of all the drugs in the parenteral and ophthalmic sections in view of the critical and major observations reported by the joint inspection team”.

It also said the Kala Amb-based firm may be directed to stop the production of potent drugs such as hormones and beta-lactam.

“Immediate administrative and regulatory measures such as cancellation of the product permission of the drugs… The firm may be directed to show cause why action should not be taken on the firm for the large number of GMP non-compliances”.

News18 tried to reach out to state and central drug inspectors for an update. However, neither the state officials nor the officials at CDSCO headquarters were willing to share details.