The Drug Controller General of India (DCGI) is expected to meet the members of the drug consultative committee (DCC) in mid-February next year to deliberate over some of the major regulatory challenges and issues faced by the officials during the recent times while implementing the same in their respective states. One of the major point of discussion during this meet will to be to get better clarity and feedback on the status of grant of product license in the generic names from the state licensing authorities (SLA's).
During the meeting the DCGI will be having a detailed discussion on the said notification with all the SLA's so as to get their status and updates on this issue. This comes as a welcome news to the industry which is still in confusion and worried over the lack of official statement from the DCGI's office clarifying the SLA's stand over the sale of drugs in the brand names as they would be issued product license in the generic names only. Officials from the DCGI's office had stated some time back that the companies could sell the product in brand names even though they have product licence only in the generic name provided that they have approval from the patent office for the same.
Dr G N Singh, DCGI clarified that most of the state licensing authorities have already started implementing the same, however there are reports that some of them are facing some problems while doing so. “Among the other major issues, we will be discussing on this matter with due diligence due to its complex nature so as to get a broader view on the same. Most of the SLA's in our understanding is handling this matter very aptly, however, we do understand that in some states there is a need for better clarity and all steps will be taken to address to the same at the earliest,” he added.
The DCC meeting is also expected to touch upon some of other major regulatory challenges and issues faced by the officials during the recent times while implementing the same in their respective states. DCC constituted under the Drugs and Cosmetics (D&C) Act to provide advice regarding uniform implementation of the D&C Act and the Rules throughout the country will be focusing on effective implementation of the pharmcovigilence programme of India (PvPI) so as to ensure better ADR reporting for the safety of the patients.
This meeting is considered to be of utmost importance as it will provide an ideal platform to deliberate on many burning issues like efficient implementation of the Schedule H and Schedule H1 to ensure the safety of the patients across the country. Focus will also be given on discussing steps that will help in making the Indian regulatory system more stringent as per the suggestions enlisted by the Parliamentary Standing Committee on health and family welfare in its report in May this year.
Along with discussion will also be done on immediate steps that needs to be taken to ensure better implementation of all the provisions as enlisted in the D&C Act.