It is only five months since India’s central drug authority launched its online licensing services portal, SUGAM. But the regulator needs to settle niggling doubts fast if it wants to catch the Digital India wave By Usha Sharma
The government launched the Digital India programme in July last year aiming to transform the entire ecosystem of public services through the use of information technology. According to the programme’s official website, the vision is to ‘transform India into a digitally empowered society and knowledge economy.’ The pharmaceutical sector followed suit with the launch of SUGAM on November 14.
Driven by the Central Drugs Standard Control Organization (CDSCO), SUGAM is envisioned as an online application system for licensing of medicines, along the lines of other e-governance initiatives of the present government. The first phase saw the launch of filing of applications for import and registration of drugs. In the second phase, the online service was extended to import and registration of medical devices and diagnostics. The website also provides a brief step wise procedure for submission of the application, processing and grant of permissions for medical devices.
During the launch of SUGAM, Dr GN Singh, DCG(I) said, “The objective of the portal is to build a transparent system and incorporate global benchmarks and practices and head towards a paper free world. It is in line with the governance initiatives in other sectors, as it intends to move to online filing of applications for various services rendered by the CDSCO.”
Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India, welcomed the government’s initiative and says, “Technology is a great enabler and we have experienced its positive intervention across sectors. SUGAM is a welcome step towards a quicker and more efficient process to submit applications for import licenses and registrations.”
Dr HG Koshia, FDA Commissioner, Gujarat, says, “e-Governance is the key to bring transparency and speed in expedition of the applications. FDCA, Gujarat was the first State Licensing Authority (SLA) to introduce web-based portals iDMLA and DMLA for submission of various applications for pharma manufacturers of Gujarat. This initiative has helped the manufacturers not only get the application process done faster but also enabled them to know the status and query, if any, through the portal.”
He adds, “SUGAM, shall definitely help make the process faster at DCG(I) office. It will also help to reduce personal visits of applicants to DCG(I) office.”
Suresh Pareek, Managing Director, Ideal Cures, informs, “The process is quite simple, which is supported with FAQs for general queries that may arise in the minds of a normal user. I think they should release an user guide which will provide a detailed step-wise process for submission of applications. It will eventually reduce mistakes, which happens during filing procedure due to lack of knowledge of the system by the user.”
Dr Kiran Marthak, Head of Clinical Development, Lambda Therapeutics, too seems positive about SUGAM and says, “The implementation has already started. The ultimate goal is to have total online submissions for every aspect in pharma industry including clinical trials, test licenses, manufacturing, marketing, license for pharmacy, import, export of products etc. This will hasten the process and it will become more transparent as there is no scope of corruption.”
Commenting on the SUGAM portal, DB Mody, Director, JB Chemicals briefs, “The CDSCO has proactively taken up online application submission system for licensing, the e-portal SUGAM in right earnest. The online system is currently operational for import and registration, medical devices and diagnostics division for registration certificate and import license. All Form 10 applications and import registrations applications can now be filed online. We expect that the service will ease registration process, which will help the CDSCO issue import licenses faster. The process will be more transparent and enable applicants to track their applications.”
The industry has a lot of expectations from the government regarding ‘SUGAM’. The industry will be able to receive approvals in set/ mentioned timeline, which will help in doing business. However, there are several glitches as well that needs to be considered by DCG(I) and other responsible authorities.
TS Jaishankar, Managing Director, Quest Life Sciences says, “Online applications by pharmaceutical manufacturers to the DCG(I) seeking approvals seems a good progress and is certainly welcome. However, the very thought that over hundreds of applications would be received by CDSCO, raises doubts about the prompt attention by the concerned regulatory officers. Unlike a manual submission where we get an acknowledgment, CDSCO should also ensure that the application is acknowledged for receipt.”
Since the mode of application is online, replies are expected to come online. Jaishankar says, “Irrespective of whether the application is made manually or online, the applicant company will always be anxious to know the progress of their application. This would mean calling on CDSCO personally or through an agent. If this continues, then the very purpose of online application is defeated.”
The government’s move towards a paper free world is a good approach, but if companies still require to conduct manual follow up then and it has not served the purpose. In order to avoid it Smetacek suggests, “The successful execution of this e-initiative will require enabling infrastructure and appropriate back-end support. All in all, this is a welcome introduction with the potential to add value for all users.”
Since the system is new, there are chances that users might get confused and ill informed about the process. Jaishankar suggests, “The application form should clearly state the place of submission. In the event of any query, the department should also send mails seeking clarifications or wherever personal interview is required with date and time of appointment. The government should not initiate e-Governance of online application unless the above factors are fully complied with. It is good to have one time pre-registration for application of the services. This pre-registration should carry manufacturing license number and expiry date. Based on it, a company can create a password to secure and safeguard the applicant.”
Koshia says, “SUGAM has been prepared with IT expertise of CDAC, a competent IT wing of DeYIT, GoI and one-time preregistration is required in order to avoid spams.”
Marthak adds, “ “Authorities need to ensure that the portal is ‘firewall’ proof and confidential information is not hacked or leaked.”
The finer nuances
Certain areas need to be identified and evaluated. Jaishankar feels, “Ideally, CDSCO should evolve a deadline for final disposal of each application and honour it. It will save an enormous amount of time, energy and cost. It is expected that CDSCO regional officers in India should have the authority to receive and dispose the files without further transferring final signature to the DCG(I).”
Commenting on the relevance of the online application process in the medical device industry while making suggestion how to make the system more user friendly, Pareek says, “It is estimated that around 70 per cent of India’s medical device needs are catered to by imports. At present the registration, procurement of licence to import medical devices and its renewal after three years, is a tedious process. With such involvement by foreign suppliers, a user-friendly online facility for submission and obtaining registration and licences to import medical devices was much awaited.”
He further elaborates, “I feel that an online portal for application submission and permissions will definitely be a boon as it will reduce the time involved with the formalities of licensing etc. However, as with other online services, it will have its disadvantages of security, the systems not being upgraded, or being down for maintenance etc.”
Mody recommends, “ CDSCO should conduct training workshops for the industry in order to effectively implement SUGAM. More than us, it is the government which can confirm whether they are satisfied with the response. We are fully supporting the government in spreading awareness about the portal to our members and the industry.”
CDSCO is reviewing the progress of SUGAM and on March 21 it issued a notice which disclosed that after a review of the functioning of the portal was decided that at the first examination stage of any application either for registration certificate (RC) or import license, addresses have been filled wrongly or if the drug strength of the drug has been incorrectly entered, then an email shall be sent to the applicant pointing out the mistake. Suggestions will be given on correct way to file applications stating that the application in its present form was rejected. The applicant could re-apply with the provision that in such cases no fresh fees will be charged.
However Jaishankar says, “There is absolutely no confidence among the manufacturers regarding the implementation of e-Governance. There is hardly any awareness about the portal among manufacturers. The government should call for a meeting of all the associations, interact with them and then finalise based on the outcome of the meetings. This way, the government can avoid unnecessary opinions from various quarters and the insecure feeling of the manufacturers, on this bold effort by CDSCO.”