The need for implementing the track and trace system in the domestic market is widely seen as a step to protect and help the quality of drugs running throughout the country. Incidentally, this strategic move is prompted by the country's earlier step in adopting the track and trace system for the drugs that are exported, so as to ensure that the quality of drugs being exported from the country are not compromised with from the point of origin up-to the point of port.
Interestingly after implementing it for the export of drugs, the government is seriously deliberating over implementation of the track and trace system for domestic supply chain in another one year. In fact it is believed that the National Informatics Centre (NIC) is already set on the task and is preparing a software, which is likely to be finalised and implemented in nine months.
Once implemented, it will be able to track the drugs all throughout the domestic supply chain, according to senior officials from the commerce ministry. This will work as the technological authentication, along with the bar-coding system now in force for exports on secondary and tertiary packaging.
Stuck in the logjam
The task force, headed by Dr H G Koshia, had recommended the adoption of SMS model and unique identification code as an ideal method for the track and trace system as it was found to be more viable and affordable to the industry.
“The task force, after detailed deliberation on the issue of track and trace and UID authentication, was of the considered view that in a country like India where multiple products are manufactured by a large number of companies, this would be a boon if applied. Initially there would be problems of application due to various reasons including financial and technical issues, but a beginning should be made so that ultimately the benefits of the system is available to all,” the task force said.
It is understood that though the report by a task force set up by the health ministry was submitted way back in 2012, no final decision was taken for a long time on its implementation. Now the government is learnt to have decided to go for the mechanism that would help any customer to trace all details of the product by reading the barcode with the help of devices like mobile.
However, the move has faced stiff opposition from a section of the industry and also the agencies like the National Pharmaceutical Pricing Authority (NPPA) which reportedly feels that the system was found to be inadequate and less comprehensive.
Pushing off implementation
All said and done, while there is an active debate going on over the implementation of bar-coding for the domestic market, it has remained to be a long contended issue for exports as well. Especially the industry has been stressing that bar-code for exports is neither practical nor an ideal solution for tracking spurious or fake drugs.
This comes in the wake of union commerce ministry's recent decision to defer the implementation of barcoding on export consignment of pharmaceuticals and drugs on primary level packaging till further notification from the ministry. The requirement of affixing barcodes on primary level packaging was to be effective from July 1, 2014. Industry has been pushing for the extension of the the same for some time now and the extension comes as a huge relief for the Indian exporters who have been expressing strong objection over bar-coding due to compliance issues and feasibility.
This it is understood has been done after reviewing the compliance report of barcode implementation of the secondary and tertiary level packaging post its implementation by the expert committee set up by the government to review the matter.
Pharmaceuticals Export Promotion Council of India (Pharmexcil) who have been advocating for the industry had been working with the government to hasten the process so that the exporters do not suffer due to this. The trace and track technology which was adopted by the government to address the issues and apprehensions about the export of spurious drugs from India, was made compulsory for tertiary level packaging from October 1, 2012 secondary level from January 1 last year.
According to Dr P V Appaji, director general, Pharmexcil, the barcoding system both for the tertiary and secondary level packaging were doing well to ensure the quality of exported pharma products and there was no immediate necessity to impose the primary level bar-coding which would be technically complex and financially cumbersome.
“As long as the purpose is met through the secondary and tertiary level bar-coding, there is no need for the primary packaging, though we are not ruling out the same. Besides, it is a costly affair for the industry,” joint secretary in the commerce ministry Sudhanshu Pandey said.
Not a practical & ideal solution
A bar-code helps in tracking and tracing the origin of drugs which in turn helps in minimising chances of genuine drugs being considered spurious, sub-standard or counterfeit. However, the exporters had pointed out that the primary level bar-coding is practically impossible, especially for small products like injections, apart from causing heavy burden on the exporters who are already hit by increasing registration costs and other non-tariff trade barriers by the developed markets. They also claim that no other country has made it compulsory for exports.
Recently the government has simplified the barcoding procedure by introducing self-certification for barcoding of secondary and tertiary level packaging of drugs which are exported from India to different countries including the regulated markets.
Even as the D-day of July 1, 2014 for implementation of barcoding on primary pharma packaging comes closer, the exporters in the country have demanded to the union commerce ministry to keep the ministry's decision in abeyance. They feel that bar-coding on primary packs is neither practical nor possible and imposes a huge financial burden on the industry.
Pleading that the implementation of bar-coding at all levels of pharma packaging, especially on primary packs, is impractical both economically as well as logistically, the exporters have pointed out that barcoding on all stages of formulation packs is not implemented in any country. This is because many formulation packs like strips, vials, etc are so small that even mandatory details such as names of ingredients, warnings, batch number, price, name and address of manufacturer are very difficult to print.
Citing a US FDA example, exporters said that it is physically not possible to put barcodes on primary packs which was evident from the fact that a similar drug tracking system was dropped from the Generic Drugs User Fee Act in USA earlier, as even the largest pharma market in the world considered tracking every individual units as 'too expensive and burdensome for manufacturers, suppliers and healthcare professionals'.
Although the US has reconsidered the matter, US FDA has been directed to issue Guidelines by January 1, 2015 so that trace and track on individual packs could be considered two years later, the industry informed the commerce ministry.
Bringing to the notice of the government about the financial burden, exporters said that every manufacturer and exporter will have to buy or upgrade machines, digitalise huge data and set up a whole new team which would require large investments and would be difficult to execute. The small and medium companies would not be able to afford setting up machinery that costs more than Rs. 1 crore and also requires additional manpower, the industry pleads. Now the exporters have demanded to the commerce ministry to withdraw the notification or at least keep the notification in abeyance.
Change of stance
In another significant decision, the ministry has notified that the mono cartons will be treated as secondary level packaging. Earlier mono cartons were treated as part of primary level packaging, now this has been modified so as to treat mono cartons as secondary level packaging.
According to the new notification, every exporter of drugs and pharmaceuticals at the time of shipment shall submit, along with other required documents, a copy of certificate of analysis issued by the manufacturer for the subject products; or a copy of certificate of analysis issued by approved laboratory of the importing country/ FDA; or a copy of certificate of analysis issued by a laboratory approved by Drugs Controller under Drugs & Cosmetics Act, 1940 and the rules made thereunder.
The exporters of pharmaceutical products should adopt a track and trace system and incorporate its features for exported medicines using barcode technology as per GS 1 global standards. In this regard, for the secondary level packaging, which is already in force from January 1, 2013, there is a requirement of incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), batch number, expiry date and unique serial number of the secondary pack. Mono cartons shall be treated as secondary level packaging in line with prevalent global packaging nomenclature.
For the tertiary level packaging, which has already been implemented in the country from October 1, 2011, there is a requirement of incorporation of barcodes (1 D) encoding unique product identification code (GTIN), batch number, expiry date and unique serial number of the tertiary pack (shipper/carton).
For the primary level packaging, for which the effective date will be notified later, there is a requirement of incorporation of 2D (GS1 data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding unique product identification code (GTIN) and unique serial number of the primary pack.
In case, the government of the importing country has mandated a specific requirement, the exporter has the option of adhering to the same and in such a case, it would not be necessary to comply with the stipulations at serial number a, b & c of para 3(i) above and if an exporter is seeking to avail exemption from bar coding prescribed by the government of India as above, the exporter is given the option to move an application to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) for this purpose, clearly specifying the nature of such an exemption in the interest of the exports from the country. Pharmexcil shall dispose of such applications on case to case basis with prior approval of government, the notification said.
Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.
Authentication features will be added in due course and integrated with the track and trace system and government will set up a central portal for tracking and tracing exported pharmaceutical products, the notification further said.
ASU objects to 2D barcode implementation
With the deadline for implementation of the 2D bar-code for tertiary packaging, manufacturers from the ASU industry wants the Commerce Ministry to consider completely exempting the sector from its ambit. This demand comes in the wake of huge economic burden that the small scale manufacturer's are forced to bear to implement the same.
Prabodh Shah, president of the Gujarat Ayurvedic Aushadh Manufacturers Association (GAAMA) pointed out that making matters worse is the fact that none of the government agencies have come forward with any financial aid or subsidy to support the industry.
“ASU is industry is not a very big and manly comprises of SMEs who are already struggling hard to make both ends meet in this changing regulatory environment and challenging market dynamics. Unlike China, the Indian government is doing nothing substantial to support the growth of the industry, which is already hampering our business interest world wide, now to make matters worse we have to deal with these additional costs as well,” Shah asserted.
He said that there is a general consensus within the industry that this technology is unaffordable for them as they are unable to cope up huge expanse associated with it. Particularly, as it requires registration and computerisation; procurement and installation of scanners, printers along with special ink for the same etc. which all rounds up to an additional cost of rupees three to four lakh. To add up to their vows the Association pointed out that the industry have to resort to either adjust money from their business or borrow money on high interest rate from private players since bank do not give any loan to the sector.
After a delay of over a year, the government had decided to implement barcoding on primary level packaging on export consignment of pharmaceuticals and drugs for tracing and tracking purpose, from July 1, 2014. If exempted, this will come as a huge relief for the Indian exporters who have been expressing strong objection over barcoding due to compliance issues and feasibility. The industry has been stressing that barcode is neither practical nor an ideal solution for tracking spurious or fake drugs.