Guidelines come against the backdrop of complaints of sub-standard Indian drugs and overseas deaths
The Union Health Ministry has notified the Revised
Schedule M guidelines under which pharmaceutical companies will have to
intimate the licensing authority about recalling a drug and also report product
defects, deterioration or faulty production.
Till now there was no provision for informing the
licensing authority about drug recall.
Schedule M part of Drugs and Cosmetics Act 1940 deals
with ‘Good Manufacturing Practices’ to be followed by pharmaceutical
manufacturing units in the country.
The new guidelines issued on December 28 state the
manufacturer must be responsible for the quality of the products so that “they
are fit for their intended use, comply with the requirements of the licence and
do not place patients at risk due to inadequate safety, quality or efficacy”.
These guidelines come against the backdrop of
complaints of sub-standard Indian drugs and deaths abroad reportedly due to it
since 2022.
The amended guidelines stress the need for stability
testing of drug substances in accordance with recommended climate conditions
with an aim to upgrade MSMEs at par with global standards, especially to those
of WHO, and ensure production of globally acceptable quality of drug.
It also specifies that release of the finished product
is conditional upon satisfactory results of these tests.
“The licensing authorities shall be informed if a manufacturer
is considering action following the faulty manufacture, product deterioration,
a suspect product or any other serious quality problems with a product,” the
new guidelines read.
Besides, the licensee shall have a pharmacovigilance
system in place for collecting, processing and forwarding the reports to the
licensing authorities for information on the adverse drug reactions emerging
from the use of drugs manufactured or marketed by the licensee.
In order to have smooth transition from the present
Schedule M to revised Schedule M, it has been decided to provide a transition
period of six and 12 months for large manufacturers (over Rs 250 crore
turnover) and MSMEs (less than Rs 250 crore turnover), respectively.
Good Manufacturing Practices (GMPs) are mandatory
standards which build and bring quality into product by way of control on
materials, methods, machines, processes, personnel and facility/environment
etc.
The GMP was first incorporated in Schedule M of the
Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was
done in June, 2005.
There are around 10,500 manufacturing units in the
country out of which around 8,500 fall under the MSME (Micro, Small &
Medium Enterprises) category. India is a major exporter of medicines to low/middle-income
countries (LMICs) which require WHO GMP certification, an official said.
“We have around 2,000 units in the MSME category in
the country having WHO GMP certification,” he stated.
The pharmaceutical manufacturing and quality domain
has developed and progressed significantly in last 15-20 years.
“Our understanding of the domain has increased because
of development in pharmaceutical and manufacturing sciences. Linkage between
manufacturing and product quality and interdependence between the two has been
established,” the official explained.
Also, observations from ongoing Risk Based Inspections
(RBI) further reiterated the need to have a relook at the current GMP
regulations and Quality Management Systems being followed by pharmaceutical manufacturers,
the official stated.
The Central Drugs Standard Control Organisation
(CDSCO) has inspected 254 manufacturing units and 112 public testing labs in
the last few months.
Major issues found during RBI inspections are poor
documentation, lack of process and analytical validations, absence of
self-assessment, absence of quality failure investigation, absence of internal
product quality review, absence of testing of incoming raw material and faulty
design of manufacturing and testing areas etc, the official said.
“Based on the above factors and to keep pace with fast
changing pharmaceutical manufacturing and quality domain, there was a necessity
to revisit and revise the principles and concept of GMP mentioned in current
Schedule M. This would bring our GMP recommendations and compliance expectation
at par with global standards, specially to those of WHO, and ensure production
of globally acceptable quality of drug,” the official said.
Accordingly, based on the discussion and
recommendation of the Drugs Technical Advisory Board (DTAB), a draft
notification was issued on October 2018 to upgrade and synchronize the Schedule
M comparable to international standards.
Large number of comments/suggestions were received
from various stakeholders and after review and multiple consultations with
them, the draft revised Schedule M was published.
Some of the major changes which will happen with
introduction of revised Schedule M to support upgradation of the units are
introduction of Pharmaceutical Quality System (PQS), Quality Risk Management
(QRM), Product Quality Review (PQR), Qualification and Validation of equipment,
Change control management, Self-inspection and Quality audit team, Supplier
audit and approval, Stability studies as per recommended climate condition,
Validation of GMP related computerized system and Specific Requirements for
Manufacturing of Hazardous products etc.
“The revised guidelines will address most deficiencies
related to documentation, failure investigation and technically qualified
personnel with right person doing the right job. It will support development of
robust quality management system in the company thereby enabling production of
globally acceptable quality medicine,” the official stated.
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