Telangana DCA issues approx 110 licenses for manufacturing hand sanitisers
Approves only those based on CDSCO-approved compositions
Reportedly, in less than three months, the State Drug Control Administration (DCA) of Telangana has issued approximately 70 new manufacturing licenses and renewed 40 existing licenses of hand sanitisers in the State.
An official from DCA informed, “The department continued issuing the licenses for hand sanitisers even during the lockdown period. From mid-March till May 27, 2020, the DCA has given total permission to approximately 110 firms for manufacturing hand sanitisers. There are three to four more firms, applied for the license and are at various stages of the scrutiny process.”
He also informed that to obtain manufacturing license of hand sanitisers in Telangana, the applicant needs to apply through Form-25 and ensure that the applied products are in line with DCG(I) approved compositions.
Firms applying for manufacturing licenses need to submit their applications through the ODLS portal. The applications should be complete with respect to the documents indicated by the authority in the respective fields of the online application form. If the applicant fails to provide complete details, then the application can be rejected by the authority.
And for the grant of manufacturing license under Forms 25, the applicant needs to pay a fee of Rs 7500, which will be considered for up to 10 products. a fee of Rs 300 will be paid for each product thereafter.
The DCA has also issued guidelines and regulatory requirements for manufacturing hand sanitisers, which are in line with DCG(I) approved compositions.
The key requirements are:
1) The applied premises should meet the requirements of Schedule-M of Drugs and Cosmetics Rules with respect to External Preparations. Although, the specific requirements should be as per Part-ID of the Schedule-M for External Preparations, as applicable for hand sanitisers.
2) The facility should meet the requirements of Schedule M Part-II 1 as well as related to the external preparations with respect to the minimum equipment and minimum area recommended for hand sanitisers.
3) If the applied premises is located in the notified industrial area, the site allocation from the Industrial Area Local Authority also needs to be submitted
4) Certificate in conformity with Factories Act for construction and starting the Unit and Permission/Consent from Telangana State. The Pollution Control Board issued to the applicant on the applied premises.
5) Permission copy should be also obtained from the Municipal Authorities/Panchayat authorities/Industrial Local Authority
Besides this, one of the key requirements mentioned in the DCA guidelines for the production and storage facilities is that they should be air-conditioned or cool rooms as the key ingredients used in hand sanitisers are ethanol (80 per cent) and isopropyl alcohol (75 per cent), which need to be stored at17.5°C and 19°C, respectively.
For obtaining the brand name, the applicant also needs to submit an undertaking via Form 51 of Drugs and Cosmetics Rules to the licensing authority.