March 20, 2002
'31'
SCHEDULE C (1) OF DRUGS AND COSMETICS RULES TO BE AMENDED
The Ministry of Health and Family Welfare has notified draft amendments proposing to amend Schedule C (1) to the Drugs and Cosmetics Rules, 1955 to include 'In vitro' Blood Grouping Sera and 'In vitro' diagnostic devices for HIV, HbsAg (Hepatitis B) and HCV (Hepatitis C). Schedule C (1) contains the list of drugs considered as special products.For the import of products covered under Schedule C (1), a licence in 'Form 10' is required to be obtained from the Drug Controller General (India), and for indigenous manufacturer a licence in 'Form 28' is required to be obtained under the said rules. A system of registration of all imported drugs has already been introduced and would be effective from January 1, 2003. The Blood Grouping Sera and Diagnostic devices for testing HIV, HbsAg and HCV are proposed to be included in the schedule to exercise proper control over the quality of imported as well as locally manufactured kits. The National Institute and Biologicals, NOIDA have started evaluation of these critical categories of kits. Such a control has become essential to provide safe blood transfusion and diagnosis of high-risk diseases.
Objections and suggestion to these amendments are to be sent to the Secretary (Health), Ministry of Health and Family Welfare, New Delhi.