Page 61 - CW E-Magazine (Oct-Nov-2023)

Happenings

in six priority areas in collaboration Govt makes GMP, Schedule withdrawal of licences and financial
with academic institutions. In addition, M mandatory for MSME penalties.
the scheme will entail spending Rs. pharma firms
3,000-crore to commercialise 30 R&D GMP standards build and bring
products and opening up seven Cen- The government has asked pharma quality into product by way of con-
tres of Excellences on pharmaceutical companies to complete and obtain trol on materials, methods, machines,
research in existing National Institutes certificate for good manufacturing processes, personnel and facility. The
for Pharmaceutical Education and Re- practices (GMP) over the next 6 to 12 Schedule M of prescribes requirements
search (NIPERs). months. Of the 10,500 manufacturers in for manufacture, control and safety
India, including MSMEs, only 2,000 of testing, storage, transport of material,
Ransomware attack them – mainly exporters – have GMP written procedures, records, traceabil-
impacts Sun Pharma’s certificates. The remaining 8,500 units ity among others.
business operations will have to complete the certification
process within 6 months or 12 months Govt. imposes conditions
After being hit by an information beginning August 1. for export of cough syrup
technology (IT) security breach in
March this year, Sun Pharmaceutical With a rising number of allegations
Industries said its business operations against made in India cough syrups in
have been impacted following the inci- various countries, the government has
dent and efforts to contain and redress imposed new conditions for export with
the situation. It also said that revenues effect from June 1. However, there is no
would be reduced in some businesses change in free export status.
as a result.
“The export of ‘cough syrup’ un-
der ITC (HS) Codes falling under the
Heading 3004 shall be permitted sub-
ject to the export sample being tested
The move comes in the backdrop of and production of Certificate of Analy-
WHO raising concerns about some of sis (CoA) issued by any of the labora-
A ransomware group has claimed the cough syrups being sold overseas, tories with effect from June 1, 2023,”
responsibility for the incident, Sun leading to the death of children across said a notification issued by Directorate
Pharma disclosed to the stock exchang- countries such as Gambia, Uzbekistan, General of Foreign Trade (DGFT).
es, without divulging the name of the Cameroon, Marshall Islands, and Fed-
group or outlining the quantum of im- erated States of Micronesia. This development has taken place
pact. This is the third high-profile cy- after the World Health Organization
ber-security linked incident on a large According to Mr. Mansukh Man- (WHO) issued another alert for an In-
Indian drugmaker in about three years. daviya, Union Minister of Health and dia-manufactured contaminated cough
In late 2020, Dr. Reddy’s Laborato- Family Welfare, companies, particular- syrup sold in the Marshall Islands and
ries and Lupin reported cyber-security ly MSMEs, having an annual turnover Micronesia. This is the third such alert
breaches. Last year, the All-India Insti- of less than Rs. 250-crore will need to within seven months for contaminated
tute of Medical Sciences was also hit by complete the certification process with- cough syrups produced in India, with
a ransomware attack. in 12 months, while those with an annu- the previous cases having been identi-
al turnover of over Rs. 250-crore, must fied in the Gambia and Uzbekistan.
While no information has been complete the certification in 6 months.
shared on the region from where the The alert asks people to not use the
online attack was possibly launched “Schedule M of the Drugs and syrup and regulators to increase surveil-
or the precise data that may have been Cosmetics Act has been amended and lance of supply chains. It also asks man-
breached, Sun Pharma said the inci- pharma companies, including MSMEs, ufacturers to test raw materials used in
dent’s effect “includes a breach of cer- will now have to transition to the new syrups such as propylene glycol, sorbi-
tain file systems and the theft of certain regime” he said. Failure will attract tol, and glycerine/glycerol before using
company data and personal data.” suspension of manufacturing activities, them in a medical formulation.

Chemical Weekly October / November 2023 57