CDSCO releases data of SQ drugs along with NSQ drugs to boost the image of Indian drug manufacturers
In a move
to boost the image of Indian drug manufacturers, the Central Drugs Standard
Control Organisation (CDSCO) has for the first time released data of drugs
declared as standard quality (SQ) by Central Drugs Laboratory (CDL) and
Regional Drugs Testing Laboratories (RDTLs) along with monthly data of not of
standard quality (NSQ) drugs.
In a list of drugs, medical devices and cosmetics declared as
not of standard quality, spurious, adulterated or misbranded, the CDSCO has
revealed that for the month of March 2019, there were 2011 drug samples tested
at four laboratories-- Central Drugs Laboratory (CDL), Kolkata, Central Drugs
Testing Laboratory (CDTL), Mumbai, Regional Drugs Testing Laboratory (RDTL),
Guwahati and Regional Drugs Testing Laboratory (RDTL), Chandigarh. Of them,
1,888 samples were found to be SQ and 50 samples were found to be NSQ.
The data of SQ and NSQ drugs was released by CDSCO on April
15, 2019 after Union health and family welfare ministry had approved a proposal
in this regard. So far CDSCO has disclosed the number of drugs declared SQ, the
list of SQ drugs and their manufacturers will soon be released in line with the
list of NSQ drugs and their manufacturers.
The proposal to issue guidelines for releasing data of drugs
declared SQ by CDL and RDTL was sent to the health ministry by Drugs Controller
General of India (DCGI) following a representation by Laghu Udyog Bharati.
Earlier, CDSCO used to release data of drugs declared as NSQ
by CDL and RDTL denting the image of Indian drug industry which accounts for 20
per cent of global exports in generics.
Taking serious note of this, Laghu Udyog Bharati had been
demanding release of SQ drug data of CDL and RDTL since last year.
Acting on their demand, DCGI had forwarded a proposal to the
ministry in this regard.
The disclosure of SQ drug data by CDSCO has brought cheers to
the drug makers.
Said Amit Chawla, vice-president of Laghu Udyog Bharati
Indore unit, “We are glad that India’s apex drug regulatory body has
implemented Laghu Udyog Bharati’s proposal to release data of SQ drugs. It will
instill confidence in people that a majority of drugs sold in the country is
safe for consumption and strengthen the image of domestic drug makers and
regulatory body.”
We had time and again stated that the NSQ data is minuscule
as compared to numbers of drugs declared SQ by CDL and RDTL. A majority of
domestic units adhere to good manufacturing practices to ensure quality and
efficacy of drugs. The list of NSQ data for March released by CDSCO had
validated our stand, he added.
Central Drugs Standard Control Organization (CDSCO Approval) is such a body that regulates the checking. They do the verification of these medical products or cosmetics etc. before they are sold in the market. They will scrutinize your products and then only provide you with the certification of authenticity.
ReplyDeleteCDSCO APPROVALS Medical Device Rules, 2017 came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO)
ReplyDeleteThe Central Drugs Standard Control Organization (CDSCO) is a regulatory body
that lays down stringent standards that any drug, medical devices, diagnostic kits, cosmetics, biologicals and vaccines being introduced into the country must meet before being sold in the market.