Union Minister Parshottam Rupala launched NANDI portal (NOC Approvals for New Drug and Inoculation System) to timely process applications and grant non-objection certification (NOC) for veterinary drugs and vaccines. 

What is the need for such a portal?

• The regulation of the import, manufacturing and marketing of veterinary drugs and vaccines comes under the purview of the Central Drug Standard Control Organisation (CDSCO) under the ministry of health. 

• However, permission for the import/manufacture of veterinary drugs, vaccines and biologicals are granted in consultation with the ministry of fisheries, animal husbandry and dairying. The present system is manual. 

• The health ministry gives final approval of drugs and vaccines. In the case of veterinary products, it cannot be given without the NOC from us. Since granting of NOC was manual, delay/obstacle from our ministry was felt. 

• So, the portal NANDI (NOC Approvals for New Drug and Inoculation System) has been launched. 

• With the portal, the regulatory approval process to assess and examine veterinary product proposals will be more streamlined through seamless integration with the SUGAM portal of the Central Drugs Standard Control Organisation (CDSCO) and Drugs Controller General of India and will also stride towards achieving the interventions laid out as part of its Animal Pandemic Preparedness Initiative (APPI).

• The launch of the NANDI portal is another notable undertaking following the animal vaccination coverage initiative and Mobile Veterinary Units (MVUs). This initiative would also provide valuable support to researchers and industries from a commercial perspective.

What is the role of DCGI?

• The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General (India) is the central authority for regulating the quality of drugs marketed in the country under the Drugs and Cosmetics Act, 1940. 

• The mission of CDSCO is to safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

• Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority are major functions of CDSCO.

• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 have entrusted various responsibilities to central and state regulators for regulation of drugs and cosmetics. It envisages uniform implementation of the provisions of the Act and Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. 

• CDSCO is constantly striving to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

• The CDSCO, with its headquarters in New Delhi has six zonal offices, six  sub-zonal offices, seven Central Drugs Testing Laboratories and nine airport & 18 sea port offices (including inland container depots).

Manorama Yearbook app is now available on Google Play Store and iOS App Store