The Drugs Controller General of India (DCGI) has instructed state drug regulators to take necessary action and direct all the manufacturers on how to upload their manufacturing sites and formulation data on Sugam portal which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country.
The DCGI’s direction came after a gazette notification vide G.S.R. 19(E) issued by the Union ministry of health and family welfare on January 10, 2019 amending the Drugs and Cosmetics Rules, 1945 by inserting Rule 84AB – data to be transferred by the licensee on online portal Sugam. As per the inserted rule, all the licensee shall register with Sugam and upload information, as per the format provided in the said portal, pertaining to the licences granted for manufacture for sale or distribution of drugs and the information so provided shall be updated from time to time and such information uploaded by the licensee shall be verified by the concerned licensing authority. The rule is effective from January 29, 2019.
Earlier the health ministry had in July last year released a draft amendment to the Drugs and Cosmetics (D&C) Rules of 1945 in this regard.
The Central Drugs Standard Control Organization (CDSCO) has launched a module under Sugam portal for uploading the data pertaining to manufacturing sites, formulation, formulation production, product production capacity. In this regard, CDSCO has also developed a user manual.
According to the manual, applicant has to first register on the portal for all his manufacturing sites separately. If already enrolled on the SUGAM portal, than Login to the SUGAM portal if not then first register and validate the account. Once the enrollment procedure is done, applicant can Login to the SUGAM portal to send the manufacturing sites and formulation information. Manufacturing sites should be entered once after that it will be brought consequently and applicant will be required to just enter all the licenses detail on this manufacturing site.
Applicant further needs to enter the formulation detail for the licenses that he selects. He/she can enter multiple formulations for same license. Once applicant submits the application it will go to state FDA for approval. All the accepted applications will be visible in verified formulation detail section.
The applicant also needs to enter the production details for each formulations quarterly/yearly basis. Finally, he/she is required to submit the volume of products that are generated by the manufacturing site.
The submitted and approved information will be available on the manufacturer dashboard of Sugam portal.
In case applicant wants any amendment in the formulation detail, he/she can communicate to the state FDA through the option ‘reply to official’ and asked for the amendment. The official can also reply back to the applicant.
Further, DCGI appealed to state food and drug administration to verify the data uploaded by the manufacturers for compliance of the provisions of the rules.
As of now there is no digitized manufacturing sites and formulation data. Details pertaining to manufacturing plants and drug formulations are rested with state FDAs. At times, state drug authority finds it difficult to share real time data with CDSCO. Sugam portal will prove to be a panacea for sharing comprehensive information on domestic pharmaceutical industry.
Drug manufacturers have welcomed the government’s initiative to make digital declaration mechanism compulsory for all units licensed to manufacture drugs in India.
Said Nipun Jain, chairman of Small & Medium Pharma Manufacturers Association (SMPMA), “We have welcomed the health ministry’s notification paving the way for digitization of manufacturing plants and formulation data. It will help CDSCO access real time-data on domestic drug units without depending on state drug authorities.”
Echoing Jain’s view, the Federation of Pharma Entrepreneurs (FOPE) co-chairman Vinod Kalani said, “Industry has extended its support to the government’s digitization endeavor. A significant number of drug manufacturers have already started uploading requisite data on plants and formulations on the portal.”