Page 144 - CW E-Magazine (14-1-2025)

Pharmaceuticals

COMPLIANCE EXTENSION
MSME pharma companies get additional one year

to upgrade facilities under Schedule M

The Health Ministry has granted The pharmaceutical manufacturing tion was published on January 5, 2024.
micro, small and medium (MSME) and quality domains have developed According to the notifi cation, units
pharma companies with a turnover of signifi cantly over the last 15-20 years. with an annual turnover of more than
less than Rs. 250-crore an additional 12 “Our understanding of the domain has Rs. 250-crore were expected to comply
months to implement the revised Good increased because of developments with the revised Schedule M stand-
Manufacturing Practices under Sche- in pharmaceutical and manufacturing ards starting July 1, 2023. For units
dule M of the Drugs and Cosmetics Act. sciences. The linkage between manu- with an annual turnover of less than
facturing and product quality and the Rs. 250-crore (MSMEs), the implementa-
These companies now have until interdependence between the two have tion deadline was set for January 1, 2025.
December 31, 2025, to comply with the been established,” the statement said.
improved manufacturing practices. The Registration in three months
extension comes following requests To keep pace with the fast-chang- To facilitate the upgradation of
from manufacturing units to upgrade ing pharmaceutical manufacturing and MSME facilities, the Department of
their facilities, the ministry said in a quality domain, the government re- Health and Family Welfare has issued
statement. vised the GMP standards in the current a draft notifi cation stating that these
Schedule M of the Drugs and Cosme- units will have three months to register
GMP norms are being implemented tics Act. “This would bring our GMP with CDSCO and share their upgrada-
in the country to improve product qua- recommendations and compliance ex- tion plans. A 12-month extension will
lity by controlling materials, methods, pectations in line with global standards, be provided until December 31, 2025.
machines, processes, personnel, and especially those of the WHO, ensuring
facilities/environments, among other the production of globally acceptable The statement also noted that after
factors. According to the ministry, there quality drugs,” the statement added. three months, an audit of these facilities
are around 10,500 manufacturing units The new Schedule M was notifi ed in will be conducted. Depending on the
in the country, of which around 8,500 December 2023. To facilitate a smooth status of implementation, action will be
fall under the MSME category. India is transition from the present Schedule M taken if the upgradation plans are not
a major exporter of medicines to low to the revised one, the government pro- being executed. To date, CDSCO has
and middle-income countries (LMICs), vided a transition period of six months inspected over 800 manufacturing units
which require WHO GMP certifi cation. for large manufacturers (with a turn- and 252 public testing labs. The feed-
Currently, around 2,000 units in the over of more than Rs. 250-crore) and back from these audits indicates signifi -
MSME category hold WHO GMP 12 months for MSMEs (with a turnover cant improvement in the implementa-
certifi cation. of less than Rs. 250-crore). The notifi ca- tion of GMP standards by MSMEs.

MEDICAL DEVICE
AI-powered pulse diagnostic device gets CDSCO nod

Nadi Tarangini, an indigenously Prof. J. B. Joshi, Chancellor, Institute Innovations, based in Hinjewadi, Pune,
developed pulse diagnostic tool, has of Chemical Technology and has been is priced at Rs. 55,000, and the company
become India’s fi rst ayurvedic medical developed by Dr. Aniruddha Joshi fol- presently has the capacity to manu-
device to receive approval from the lowing over six years of research at IIT facture 5,000 devices per year.
Central Drugs Standard Control Organi- Bombay. It combines ultra-sensitive
zation (CDSCO), the national regula- sensors with cutting-edge algorithms to Currently, it is being used in more
tor for cosmetics, pharmaceuticals, and deliver precise pulse readings that can than 1,250 Ayurvedic clinics across the
medical devices in the country. help ayurvedic practitioners. country and so far, more than 5-lakh
individuals have been tested with this
The device is the brainchild of The device, manufactured by Atreya device.

144 Chemical Weekly January 14, 2025

Contents Index to Advertisers Index to Products Advertised