Page 152 - CW E-Magazine (30-4-2024)

Pharmaceuticals

CURBING SUBSTANDARD MEDICINES
CDCSO issues draft guidelines on good distribution

practices for pharma products

The country’s drug regulator recently hold a ‘quality system.’ It further stated All customers and competent authori-
released draft guidelines on good distri- that a responsible individual must be ties in all nations where a specifi c pharma-
bution practices to prevent the entry of designated by the management for every ceutical product may have been distri-
‘spurious,’ ‘adulterated,’ and ‘sub-standard’ distribution site, with specifi ed authority buted must be promptly notifi ed of any
pharmaceutical products in the market, and accountability to ensure the imple- plans to recall the product. The returned
news agency PTI has reported. mentation and maintenance of the ‘quality products shall be destroyed in accordance
system.’ with “international, national and local
The draft guidance document, issued requirements” and with due consideration
by the Central Drugs Standard Control The guidelines specify that any to protection of the environment unless it
Organisation (CDSCO), aligns with the deviations from the approved procedures is certain that their quality is satisfactory,
WHO Technical Report Series (TRS) on must be recorded and examined. It was after they have been critically assessed in
good storage and distribution practices mentioned in the guidelines that suitable accordance with a written and authorized
for such products. corrective and preventive action (CAPA) procedure, the document said.
should be implemented to rectify devia-
The guidelines are set to apply to all tions and prevent their occurrence. Records for the dispatch of pro-
individuals and establishments engaged ducts should include a description of the
in any phase of the storage and distri- The document mentioned that if a products including name, dosage form
bution of pharmaceutical products, starting product requires a recall, it should be and strength (if applicable), quantity,
from the manufacturer’s facilities to the separated during transportation and dis- assigned batch number and expiry date,
individual dispensing the products to tinctly marked as ‘recalled products.’ among other details. It shall be ensured
a patient or their representative. In cases where segregation during transit is that records of dispatch contain enough
unfeasible, these items must be securely information to enable traceability of the
“Not of standard quality and spuri- packaged, clearly labelled, and accom- pharmaceutical product, the draft guide-
ous products are a signifi cant threat to panied by suitable documentation. lines said.
public health and safety. Consequently,
it is essential to protect the supply chain PLANT INSPECTION
against the penetration of such pro- USFDA issues Form 483 to Marksans
ducts,” reads the draft ‘Guidelines on
Good Distribution Practices for Pharma- Pharma’s Goa unit
ceutical Products’.
Marksans Pharma said the US health tional observations in Form 483,”
The document outlines measures to regulator has issued a Form 483 with Marksans Pharma said. As per USFDA,
aid stakeholders in meeting their obliga- fi ve inspectional observations after Form 483 is issued to a fi rm’s manage-
tions at various phases within the supply inspecting its manufacturing facility at ment at the conclusion of an inspection
chain to prevent the entry of ‘sub-standard’ Vema, in Goa. when the investigator has observed any
products in the market. conditions that may constitute viola-
The US Food and Drug Administra- tions of the Food Drug and Cosmetic
The draft suggests incorporating tion (USFDA) had conducted a routine (FD&C) Act and related Acts. There
self-inspections by a designated, com- current Good Manufacturing Practices is no data integrity observation, the
petent individual in an independent (cGMP) inspection at the manufactur- company informed.
and detailed manner within the ‘quality ing facility from April 9-17, 2024, the
system.’ company said in a regulatory fi ling. The company will work closely with
the USFDA and is committed to address
All distributors of pharmaceutical “On conclusion of the inspection, these observations comprehensively with-
products are required to create and up- the company has received fi ve inspec- in the stipulated time, the fi ling said.

152 Chemical Weekly April 30, 2024

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