Ravi Mathur, CEO, GS1 India speaks to Viveka Roychowdhury on the importance of each healthcare provider having a Global Location Number (GLN), linked to a national hospital registry. The GLN system ensures patients get more transparent information about the prices and services available and also helps detect and prevent medical insurance fraud
Give us some background on GS1 and its responsibilities in India.
GS1 India is the India affiliate of GS1, an international standards body headquartered out of Brussels. GS1 has a direct point of presence in 140 countries. Our job in India is to connect companies from the Indian market place as well as introduce the Indian industry to the existing global practices in terms of the identification standards and to assist the industry in implementing those standards from a perspective of firstly, compliance with regulatory requirements, both in India as well as overseas, Secondly to meet industry requirements for identification standards. For instance, for manufacturers this would mean barcoding and identification standards on products at retailers as well as e-tailers across the world.
We are responsible for GS1 operations in India. We are set up by the Ministry of Commerce and Industry, Government of India. Our founding members are apex trade bodies like CII, FICCI, ASSOCHAM, FIEO, IMC, BIS, APEDA, and IIP. We help the industry in adopting global GS1 standards in their supply chains to enhance efficiency and profitability. GS1 India is headed by an additional secretary in the Ministry of Commerce.
In the past 21 years of our existence in India, retail has become more organised and modernised through big retail chains, all products now incorporate barcode and have a unique number called the GS1 number, which has a unique identity across the world. By scanning a consumer product at the point of sale, what we capture is this unique code which gives all information about that product in the point of sale (PoS) system of the retailer or e-tailer. Through this we are able to do consumer billing, stock management, etc. capturing the information in the system in a very accurate and immediate fashion. The same thing also applies to pharmacies and chemists across the world.
Incorporation of GS1 standards has been a relatively recent phenomenon in India, though it was incorporated by the Director General of Foreign Trade (DGFT) as early as 2011 for medicines being exported. The perspective was that trace and trace and authentication mechanisms were required due to the large incidence of spurious drugs in the market. It was necessary to protect the brand image of India across the world with GS1 standards in line with global practice. Therefore it was mandated that Indian medicines for exports should also incorporate barcodes using GS1 standards and the data on all the daily production should be loaded onto the Drug Authentication and Verification Application (DAVA) portal, run by National Informatics Centre (NIC). More than 380 large and medium sized pharma companies currently upload their daily production data to the DAVA portal.
What has taken time is for the same thing to happen for medicines domestically sold in India. This has taken time because there hasn’t been a complete congruence of views between the Department of Pharmaceuticals, the Ministry of Health and the Drug Controller’s office. There has been a lot of conversations that have been happening. GS1’s view was that it should be aligned with what’s happening for exports. There should be no difference because its the same pharma companies, whether they supply to India or export it anywhere in the world. By and large, 75 per cent of those companies are common. This also prevent errors at the retail level because even different strengths of the same medicine would have different unique codes. So having different GS1 codes would make it quite difficult for a chemist to make a mistake. This would reduce the consequences of such medication errors.
Though they have not yet taken a call on this at an industry level, some organisations have been doing it independently of the directives from the Ministry of Health & Family Welfare, or the Department of Pharmaceuticals or the Drug Controller General (India) (DCGI) office. For instance, the hospitals belonging to the Army have already gone ahead (they receive the material by scanning the GS1 barcode applied by suppliers).
For instance, as per Tender Ref. No.: BPPI/LTD./DRUG-105/2019 dated July 3 this year, one of the eligibility criteria to apply for the Bureau of Pharma PSUs of India (BPPI) tender is that the tenderer is required to incorporate bar codes as per GS1 standards at various packaging levels (primary, secondary and tertiary) (Annexure I) and they are required to submit valid registration certificate from GS1 India for such barcoding.
The BPPI has mandated barcoding medicines at the manufacturer end at the tertiary packaging, secondary and primary level before it reaches the warehouses for the Jan Aushadhi outlets. The consignments are inwarded by scanning the tertiary level as they are received into the BPPI warehouses. The objective for barcoding at secondary and primary level is to scan and outward from warehouse and Jan Aushadhi Kendra’s. Ideally this is done by the manufacturers, the pharma companies, like the way it is done by all consumer products, at the primary, secondary and tertiary packaging levels. This is a system they have put into place until such time that the DCGI mandates a notification or domestic market.
If the parent-child relationship at all three levels cannot be mapped, them someone can duplicate the label. Duplication is normally happening by copying the label and the barcode, etc at the primary level. But what cannot be duplicated is the mapping between the parent and the child. Because the person trying to duplicate does not have the mapping information which is captured at the manufacturer level. The manufacturer can use technology in the factory that the counterfeiter will not have access to. This is why parent-child tracking is very important.
What is the process to tag hospitals with a Global Location Number (GLN) and how does ROHINI, the National Registry of unique Indian hospitals, play into this process?
The GLN is the unique identification of a legal entity that is a private hospital. Prior to this unique identity, every hospital follows its own system of identification which is not uniform. The issue arises when insurance companies have to settle claims. Media reports have highlighted that national insurance companies are incurring huge losses due to frauds. There is a proposal to merge all these insurance companies due to these heavy losses.
Frauds are happening at two levels. One, in many of the insurance claims cases found to be fraudulent, these hospitals do not even physically exist. Secondly, even if the hospitals exist, the medical claims are false. The challenge was, there was no way for the insurance companies to do a physical check if the hospital existed or not for each claim raised by the 40000-50000 private hospitals in India.
Now each hospital can be given a unique identity location number, the GLN, which is also the way hospitals all over the world are identified. Each hospital can be uniquely identified by this GLN. This is like the Aadhaar number. No one person can have two Aadhaar numbers. We can have two ration cards or even two PAN numbers but only one Aadhaar number. This is what the location number does. The same number will not be given to any other hospital. This number can be linked to its GPS coordinates as well as an image of the hospital. Thus we are also capturing the geotag position and linking it to GLN.
When the Insurance Regulatory Development Authority of India (IRDAI) first decided to set up a hospital registry in the country, they had a consultation with us to understand the best way to uniquely identify a hospital. We shared the GLN as the best global practice for this task. This number can be referred to by any hospital in the world. The IRDAI decides what are the reasonable prices of various surgeries in private hospitals across the country, by considering the prices across hospitals and arriving at an average price. Insurance companies reimburse patient claims, as part of mediclaim, upto the amounts which have been approved by IRDAI.
IRDAI gets complete visibility as well as of the treatment costs at each hospitals. This helps IRDAI evaluate the correct price for each treatment. And from a consumer/patient angle, you can get complete transparency of the treatment costs at different hospitals before availing medical facilities. But for that you need a hospital registry which needs a unique identification system of hospitals. And that is what we provide. IRDAI launched ROHINI, the national registry of Indian hospitals, in November 2015.
What percentage of the total hospitals in India are part of the network? What are the plans to increase this number?
It currently lists approximately 33000 unique hospitals and medical day-care centres, which is approximately 50 per cent if you consider that India has a total of 50000-60000 private hospitals. The Insurance Information Bureau of India (IIB), headquartered out of Hyderabad, promoted by IRDAI, is responsible for running ROHINI. The mandate is to get all private hospitals in the country to join the registry. They have a programme to get them progressively on board.
What are the other uses of the GLN system?
The GLN is also very useful if you want to build a repository of other entities offering medical services like say, all laboratories or blood banks in the country. I think this is another thing which should be done at a government or regulator level. Having each of these medical facilities uniquely identified would make it easy for the government to manage them.
How would such a GLN/unique identifier system benefit Ayushman Bharat (AB), where the NHA has detected huge frauds?
From an AB perspective, which involves both public as well as private hospitals, having a common identification system would make it very easy for the government to have data on treatment costs. The funding allocated for AB is quite substantial and this system will give them access to data to conduct deep analytics in terms of say, how many patients in which such uniquely tagged hospitals are availing of what treatments. Such rich analytics can help the government do very targetted transfers and allocation of funds. This can even be drilled down to medicines and medical devices. Imagine if all the data on medicines, medical devices used, treatments done for all patients in all hospitals are linked and captured. Pharmaceutical companies too would get to know the consumption and usage patterns of medicines across the country. This would be able to give information of shortages or excesses of medicines, etc.
As of now ROHINI covers only private hospitals, the public government hospitals are not part of this initiative, right?
Yes, because unfortunately the government has been following their own system for government hospitals. But there really should not be two different systems. It should be one system. As of now there is no direct connection to AB but we have represented all these benefits to the National Health Agency, the NHA, that it would be very beneficial if they were to issue instructions that this system should be used.
This has been the current global practice for the past 40-45 years so we are not suggesting anything new for India. It will help international patient referrals as well; both international patients coming to India for treatment as well as patients from India going overseas. Even electronic health records (EHRs) need to be identified uniquely as per a globally standardised system. This is what GS1 is involved in: standardisation and unique identification of medicines, medical devices, hospitals and EHRs. This would make them all interoperable globally. The benefits range from counterfeit detection, to track and trace for product recalls. These are the kind of things that can be done if such standardisation is adopted.
The Ministry of MSME used to give financial support to MSME pharma companies to implement these (barcoding) measures but unfortunately this has been discontinued in the last few years. Is there any funding for hospitals to go through this process?
No, this scheme is not available for hospitals. The annual cost of a hospital joining the ROHINI network is just Rs 1000 so cost should not be a show stopper. In the case of the pharma sector, the cost of GS1 barcoding is a very small cost of the overall cost of a pharma plant. The major capital costs and investment of pharma companies is putting up the process manufacturing plant. In comparison, putting barcodes to meet standards are smaller incremental costs. It is a one time cost and work involved to equip the production lines to deposit these barcoding machines. So I don’t think that should be a show stopper for even the smallest of pharma companies.
The other thing is, the industry is saying that the parent-child tracking is difficult to do. Yes, this does call for some discipline to record (match) the batch numbers on the products being put into outer boxes. The argument that this needs a lot of cost is not a fair argument. Logically, manufacturers should have been doing it anyway, right? At the end of the day, this is what is required to stop duplication, address the counterfeit problem, for product recalls, authentication. I think that is a small cost to pay which the industry should bear. That’s the benefit for the consumer, for the common good, not just in India but all across the world. For exports, you in any case don’t have a choice. So why shouldn’t you do it also for India? That’s our perspective. I think implementing GLN needs a mind set change. And if it is for the benefit of the consumer/patient, I think the mindset should change.
How does GLN help to reduce medical data errors and redundancy in the records?
At the global level they have a lot of things coming out from the patient safety angle, for instance on EHRs. As the European Union is one single block, they are able to do a lot of things across the 46 EU countries. The other thing that was presented to the government was on medical device identification and creation of implant registries in the country. Today we don’t know which medical device like a stent or implant like a orthopaedic implant was given to which patient and where. Worldwide, these are covered by GS1 standards so the regulators know which patient in which hospital has which implant/device. Most medical devices in India are imported. This is why we suggested that the same GS1 standards in use for medicines should be used for medical devices as well.
You don’t need to re invent the wheel, but to integrate with the rest of the world.
If the regulator keeps giving concessions to local industries to defer/ delay such moves, it will be counterproductive. In the long run India will get isolated as a country. And that’s not in our interests.