Mumbai : The Maharashtra Food and Drugs Administration (FDA) has set timelines for various regulatory approvals with an aim to make approval process transparent and facilitate ease of doing business.
On August 22, 2022, FDA came out with a circular prescribing timeline for various applications. As per the circular, the prescribed timeline for drug manufacturers’ plant layout approval is 14 days. Similarly, the prescribed time period for grant for new licences, loan licences is 35 days and 14 days respectively. The prescribed time period for brand change approval is 4 days.
The state FDA will grant approval for additional product from the same site for export in 10 days while approval for additional product from the same manufacturing plant for domestic market will be issued in 20 days, stated the notice.
The prescribed timeline for grant of various certificates viz, WHO-GMP certificates, certificate of pharmaceutical product (CPP or CoPP) is 7 days. The time prescribed for district and division offices is seven working days. The time prescribed for head office is five working days. As per the rule, applicants are required to submit an application for grant of WHO-GMP certificates to Central Drugs Standard Control Organisation (CDSCO) and state FDA. The application scrutiny is conducted by CDSCO followed by joint inspection of the manufacturing plant by CDSCO and FDA inspector. Deficiencies, if any, observed during joint inspection are communicated to manufacturers. Once manufacturers submit a compliance report, it is verified by the state FDA and grant of WHO-GMP certificate along with products is recommended.
The state FDA has provided an online software system for grant of WHO-GMP certificates, CoPP etc.
Timelines are prescribed for the disposal of application after the recommendations of joint inspection team and CDSCO vide circular dated May 31, 2022.
Dr DR Gahane, joint commissioner, headquarters, controlling authority, FDA, Maharashtra, “Earlier there was no timelines for approval of various applications. For the first time, we came out with specific timelines for various regulatory approvals. It will make the approval process transparent and facilitate ease of doing business.”
He was speaking at “Reinvigorating India’s Pharma Exports: Awareness Workshop on Export Incentives” held by the Pharmaceutical Export Promotion Council of India on August 26, 2022.
Dr Gahane said besides this, we are also planning to issue CoPP certificates with digital signatures which can be downloaded by manufacturers at their premises. It will further facilitate ease of doing business in the state, he added.
He also shed light on collaborative support of FDA to manufacturers and exporters for regulatory compliance to international standards.