REVISED DRUGS AND COSMETICS RULES, 1945 - SCI &
TECH
News: Health
Ministry revises pharma manufacturing rules under Schedule M
What's in the news?
● With
an aim to bring better compliance with quality standards, the Ministry of
Health and Family Welfare (MoHFW) notified the revised rules under Schedule M of the Drugs and Cosmetics
Rules, 1945, in the Gazette of India.
Key takeaways:
● The Drugs and Cosmetics Rules, 1945
are the rules which the government of India established through the Drugs
and Cosmetics Act, 1945.
Drugs and Cosmetics Act, 1945:
●
The
Drugs and Cosmetics Rules, 1945 are the set of rules under The Drugs and Cosmetics Act, 1940.
●
It
contains provisions for the classification
of drugs under given schedules.
●
It
also contains the guidelines of drugs for their storage, sale, display, and
prescription of each schedule.
Schedule M:
● Schedule M prescribes the good manufacturing practices (GMP) for
pharmaceutical products.
● It includes requirements of facilities
and their maintenance, personnel, manufacture, control, safety testing, storage
and transport of material, written procedures and records, and traceability for
pharmaceutical products.
Revised Drugs and Cosmetics Act, 1945:
Changes in Schedule M:
Some of the major
changes introduced in the revised Schedule M include
● Introduction of a pharmaceutical quality
system (PQS)
● Quality risk management (QRM)
● Product quality review (PQR)
● Qualification and validation of equipment
● Computerised storage system for all drug
products.
Parts in Schedule M:
● The revised Schedule M has 13 parts which
provide GMP guidelines for the specific requirements for manufacturing
pharmaceutical drugs.
● The revised rules include five new
categories of drugs that were not previously covered under the erstwhile rules.
New Categories:
● The new categories include pharmaceutical
products containing hazardous substances
such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances,
biological products, radiopharmaceuticals, phytopharmaceuticals and
investigational pharmaceutical products for clinical trials for humans.
Implementation:
● The revised rules will be implemented on
the basis of company turnovers.
● Medium and small manufacturers with an
annual turnover of less than Rs 250 crore will have to implement the revised
rules within 12 months from its date of publication.
● Large manufacturers with an annual
turnover of over Rs 250 crore will be given six months to do so.
Go back to basics:
Central Drug Standard Control
Organisation (CDSCO):
●
CDSCO
is the National Regulatory Authority
(NRA) of India.
Headquarter -
Delhi
Functions:
●
The
Drugs & Cosmetics Act, 1940 and rules 1945 have entrusted various
responsibilities to central & state regulators for the regulation of drugs
& cosmetics.
●
It
envisages the uniform implementation of the Act & Rules for ensuring the
safety, rights and wellbeing of the patients.
●
Under
this act, CDSCO is responsible for:
o
Approval of Drugs
o
Conduct of Clinical Trials
o
Laying
down the standards for Drugs
o
Control
over the quality of imported Drugs in the country
o
Coordination
of the activities of State Drug Control Organizations
o
Bring
out the uniformity in the enforcement of the Drugs and Cosmetics Act.