Page 150 - CW E-Magazine (16-1-2024)

Pharmaceuticals

MANDATORY COMPLIANCE
Centre imposes stringent quality controls on pharma

fi rms

The Centre has tightened rules to According to a Union Health Minis- pharmaceutical quality system (PQS),
ensure mandatory compliance with try offi cial, of the 10,500 manufactur- quality risk management (QRM), pro-
good manufacturing practices, which ing units in the country, around 8,500 duct quality review (PQR), qualifi cation
look at bringing in quality control on fall under the MSME category. Around and validation of equipment, change
materials, machines, processes, person- 2,000 MSMEs, mainly exporters, have a control management, self-inspection
nel, and facilities, by pharma companies. WHO GMP certifi cation. “The CDSCO and quality audit team, supplier audit,
has inspected 254 manufacturing units and approval, among others.
All pharma companies must follow and 112 public testing labs till now.
the revised good manufacturing practi- Major issues found during inspections While the industry has welcomed the
ces and comply with the rules over are poor documentation, lack of pro- revision of rules, several analysts said
6-12 months. While for small com- cess and analytical validations, absence that implementation and compliance can
panies or MSMEs with a turnover of of self-assessment, absence of quality become a challenge for smaller pharma-
less than Rs. 250-crore, compliance failure investigation, absence of inter- ceutical companies.
and certifi cation processes are to be nal product quality review, absence of
completed over a 12-month period, testing of incoming raw material, infra- According to Mr. Sudarshan Jain,
larger ones or those with a turnover structural defi ciency to avoid cross- Secretary General, Indian Pharmaceuti-
more than Rs. 250-crore need to put in contamination, absence of professionally cal Alliance, the revision of Schedule
place these compliances over the next qualifi ed employees, faulty design of M will elevate the quality standards of
six months. manufacturing and testing areas, etc,” medicines. “Regulations of Schedule M
the offi cial told Businessline. will help ensure compliance with inter-
The rules were notifi ed recently, national quality standards and will bene-
thereby making good manufacturing Major changes fi t both patients and the industry by pro-
practices and adherence to Revised Major changes post notifi cation of moting the manufacturing of safe, effec-
Schedule M mandatory for everyone. rules will lead to the introduction of a tive, and high quality drugs,” he said.

SAMPLE SURVEY
Steady growth in forecast for Indian pharma sector

in FY24

Credit rating agency ICRA focus on complex generics, specialty The projected revenue growth in
expects the revenues of a sample set of drugs, easing of pricing pressure, and FY24 will be primarily supported by
25 Indian pharmaceutical companies some benefi ts of volume expansion and 11-13% expansion in the US market
which account for 60% of the over- better pricing due to product shortages and 7-9% growth in the domestic market,
all revenues of the Indian pharma- in the US market. while revenues from the European market
ceutical industry to expand by 9-11% in and emerging markets are expected to rise
FY24, compared to 10% over previous ICRA expects the overall credit pro- by 11-13% and 13-15%.
year. fi le of the Indian pharmaceutical com-
panies to remain healthy, supported The US has always been a key mar-
The operating profi t margin (OPM) by their stable earnings profi le, com- ket for most leading Indian pharmaceu-
for the sample set is projected to fortable leverage and coverage metrics, tical companies, accounting for a sizable
improve to 22-23% in FY24, against and strong liquidity position, in spite of share of their revenues. However, the
20.7% in FY2023, supported by new the credit risk arising from any adverse share of revenues from the US market
product launches backed by increased regulatory actions. for ICRA’s sample set of companies

150 Chemical Weekly January 16, 2024

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