‘SUGAM’ Pathway for Pharmaceutical Products in India: An Easy Approach

 

Raghotham S, Balamuralidhara V.*, Sidharth Malhotra

Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagar, Mysore–570 015, Karnataka, India

 

ABSTRACT:

Pharmaceutical Industry is having tremendous growth in India. Central Drug Standard Control Organization (CDSCO) is the National Drug Regulatory Authority under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India and is responsible for put down the standards and assuring safety, efficacy and quality for Drugs, Approval for Clinical Trials. SUGAM is the online portal for submission of the various applications related to drugs, ethics committee, clinical trial, medical device, vaccines and cosmetics to CDSCO in India. The objective of the SUGAM is to adopt paperless grant of various clearances by CDSCO, consolidate the Indian Drug Regulatory Framework by streamlining the CDSCO processes, permit higher level of transparency in drug regulatory processes. SUGAM is launched by the Ministry of Health and Family Welfare. The intentions of current study is to apprehend the software and online portal requirements and registration process of Pharmaceutical Products in India. The various applications that are submitted through this portal are permission to import drugs, medical devices, cosmetics and biological Permission to conduct clinical trials and BA-BE studies etc. SUGAM plays a major role in Pharmaceutical regulatory sector by making submission more simple and easy. This portal has taken India, a step ahead in the approval of pharmaceutical products.

 

 

 

INTRODUCTION:

Till the eighteenth century the exercise of medication in India became completed in line with the ayurvedic or ancient VedicHindu system. Within the early 19th century, the British government of India couldn't entrust the health care of their very own people inside the palms of Ayurveda and unanis and that they needed to deliver medical guys from Europe. Then the allopathic drugs came into lifestyles.^[1].

 

The Indian pharma enterprise, that is anticipated to grow over 15% per annum among 2015 and 2020, will outperform the global pharma industry, Indian companiesobtained 55 Abbreviated New Drug Application (ANDA) approvals and Sixteen tentative approvals from the US Food and Drug Administration (USFDA) in 2017. The country accounts for around 30%(by volume) and about 10%(value) in the US$ 70-80 billion US generics market^[2].

 

The Drugs and Cosmetics act, 1940 and rules 1945 have entrusted numerous obligations 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 below for ensuring the safety, rights and health of the patients by regulating the medicine and cosmetics. Under the Drugs and Cosmetics act, CDSCO is chargeable for approval of new drugs, Conduct of clinical trials, laying down the standards for drugs, control over the quality of the imported drugs in the country and coordination of the activities of State Drug Control Organization by Providing expert advice with a view of bring about the uniformity inside the enforcement of the Drugs and Cosmetics act.^[3].

 

The allopathic medicines are the modern ones developed on the back of science in medicine. Hastily developing digitization in the world of healthcare and its accessory outfits, the Indian Government has chosen to enroll in the foray and journey the virtual wave^[4]. As part of implementation of e-Governance, the Central Drugs Standard Control Organization (CDSCO) has decided to improve the security for pre-registering the applicants for the services rendered by them. An online licensing portal of CDSCO has been launched on 14 November, 2015 and has been named “SUGAM”. Ministry of Health and Family Welfare launched the SUGAM Portal which is spam free portal, fast and reliable.The whole process has emerged as a complete, one-time process wherein applicants can continuously get right of entry to their profile and the status of the application and can make the necessary amendments to their applications inonline^[5].

 

SUGAM:

Portal used for application and grant of licence or permission for the following:

1.    Blood Bank License.

2.    NOC to manufacture unapproved drugs for the purpose of export.

3.    Conduct BA/BE studies.

4.    NOC to obtain test license for unapproved or new drugs.

5.    Registration for import of cosmetics.

6.    Indigenous manufacture and Import of Medical device and Diagnostics.

7.    Registration for global clinical trial.

8.    Pay Online any fee as required for all above applications in a Secure and convenient manner and Save time.

9.    Import of drugs for the purpose of test or analysis.

10. Import of drugs for personnel use,

11. Registration for import of drugs.

12. Indigenous manufacture and Import of Biologicals including rDNA.

13. Registration of Ethics committee.

 

Benefits of the System:

·      SUGAM portal provides the single window for all its stakeholders to access the services provided by the portal by implementing role based access control and actions.

·      It has consolidated the entire Drug Regulatory framework at centre and provides a centralized dashboard for the monitoring the various regulatory clearances all over the country.

·      SUGAM portal provides high level of transparency to its stakeholders as status of the submitted applications can be tracked from applicant dashboard.

·      SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/license, online payment,online review process, query management and grant of permission/license online.

·      SUGAM provides a framework for viewing and replying to the deficiencies raised during processing^[6].

 

Registration Steps:

1.    Open the link "cdscoonline.gov.in" and click on "Sign Up Here" (highlighted) to register yourself,as shown in Figure 1.1

 

 

Figure 1.1CDSCO Home Page for Registration in SUGAM Portal

Note:

·        Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary can register in the SUGAM Portal as an Applicant.

·        Manufacturing Unit cannot directly register on the portal.

·        Corporate will create login credentials for the manufacturing unit and those credentials can be utilized by the producing unit for login at the portal.

 

2.      Next click on LOGIN/SIGN UP link to register on the portal, a new window will open, as shown inFigure 1.2 to sign up or login.

 

Figure 1.2 Login Page for Registered Member.

 

3.      Select “Sign Up Here” icon to register as new user, a new window will open, as shown in Figure 1.3 to select the type of application.

 

Figure 1.3 List of Registration Purpose in SUGAM portal

4.      Upon selection of the type of application the form as shown in Figure 1.4. appears and the form is Registration Form

 

 

Figure 1.4 Registration Form for Applicant

 

Note:

·        Corporate email id can be used as Username and it should be unique, which can be used as user name for future use.

·        The length of the password should be at least 6 characters long with at least one lowercase,one number, and one uppercase letter and one special character.

·        ID Proof Details, Power of Attorney and Corporate Address Proof documents should be uploaded by the User and user should keep these documents ready in PDF format before sign up process.

·        If you select the checkbox for “Do you want to receive SMS alerts?” at the time of registration, you will receive the registration and verification message on your registered mobile number.

·        User can register by filling the form as shown in Figure 1.4

 

 

Note:

·        After clicking on submit button, a confirmation link will be sent to user’s registered email id to verify registration.

·        The link will be sent to the registered email-id so that user can activate by it.

·        When user will click on the verification link sent to user's registered email id ,application will be sent for approval to the concerned authority(CDSCO Officials).

·        The approved application will be sent to the user registered e-mail id.

·        In case of rejected application, a rejection mail will be sent to user’s registered email id.

 

5.      Enter Login Credentials in the sign in box and click on "Login"(highlighted), as shown in Figure 1.2.

 

Note:

·        It is advised for the user to check their valid registered email id and valid registered phone number from time to time, because all the communication before successful registration process will be done through user's valid registered email id and phone number (via SMS ).

 

 

Registration process in SUGAM portal:

 

 

DISCUSSION:

 

CONCLUSION:

Overall review of the online service for filling applications for import registration of Cosmetics have been carried out and it has been observed that in recent months there is a continuous rise in the percentage of online applications vis-s-vis offline mode. The increasing trend towards filing online applications by the applicants are very encouraging since more than 449 approvals have been granted through SUGAM portal. This trend commensurate with the Government’s vision of Digital India.

 

REFERENCES:

1.       http://naturalhealthperspective.com/tutorials/allopathy.html

2.       https://www.brandindiapharma.in/pharmaceutical-Industry-analysis-market-research/

3.       https://cdscoonline.gov.in/CDSCO/homepage#

4.       https://www.verywell.com/what-is-allopathic-medicine-2249039

5.       https://cdac.in/index.aspx?id=st_egov_sugam_ad

6.       http://www.morulaa.com/cdsco/cdsco-sugam-portal-benefits-and-limitations/

7.       https://www.brandindiapharma.in/pharmaceutical-Industry-analysis-market-research/

8.       http://www.morulaa.com/cdsco/sugam-online-portal-a-brief-overview/

 

 

Accepted on 12.07.2018        © RJPT All right reserved

Research J. Pharm. and Tech 2018; 11(10): 4635-4639.