The pharma industry has lauded the Central Drugs Standard Control Organisation (CDSCO’s) recent move to allow the import of drugs with less than 60 per cent residual shelf life. It is a temporary action taken to ease movement of goods due to pandemic coronavirus condition across the globe, but the industry feels that the revised guidelines will give act as a breather, not only for pharma companies but also patients.
Sandhya Shenoy, Associate Vice President, FDC said, “The DCGI has made provisions to import drugs with a residual shelf life of less than 60 per cent under special conditions with proper justification. It can allowed only if it is for the purpose of testing and analysis or to manufacture formulations for export, or drugs meant to treat rare diseases, orphan drugs or in case of an emergency situation. The current situation is unique due to the COVID-19 crisis. Lots of drugs are piled at the ports due to lack of manpower and the lockdown situation and they are losing their shelf life. Also, patients need to have timely access to these medicines. Public health is a priority and in the current situation, we cannot afford to burden the healthcare system with patients who normally would not require special attention or hospitalisation. At the same time, it needs to be ensured that the potency and safety of these products are not compromised.”
A Delhi -based pharma consultant, V N Nagpal, Regulatory Consultant, M N Solutions said, “It is certainly a good move by the government and it is going to help the end-users, i.e.; patients. Based on the company’s consideration, there are possibilities that they decide to give those products at much cheaper prices. Besides this, there will be surety of availability of drugs in the product which will ensure the continuous supply of the medicines. Hence, overall, it is a good move and will favour both, industry as well as patients.”
PV Appaji, Founder Executive Director and retired Director General, Pharmexcil said, “Relaxation in residual shelf life for imported drugs is a good proactive step taken by DCGI for ensuring adequate availability of required drugs during this pandemic. It will mainly help APIs and biologicals. The import with a declaration to the port officer and for a very limited period of maximum three months is a cautious proactive measure.”
Manmohan Taneja, Assistant State Drugs Controller- FDA, Government of Haryana said, “It is provided in exceptional cases, however, it gives the power to allow the import of drugs having a lesser shelf – life. Ultimately, it will benefit both, the companies as well as the patient. Since India largely imports raw materials, with these revised guidelines certain medicines made from those materials will still have nearly 12 months expiry. In such a crucial time, a few months’ add-on will act as a relief and ensure availability.”
Extenuating circumstances….
The concept of residual expiry implies that adequate time must be available for the consignment to be imported for its transportation and clearance from customs and reach to the warehouses of the customers. Then it will follow its own distribution and ultimate passage to the actual consumer. Many a time, the importers insist on an available (residual) shelf life of 80 per cent of the assigned time period for its usage. However, under the prevailing conditions for the last couple of months, when the road, air and sea transport have been badly impacted, some consideration of reduction in residual shelf-life may be negotiable. It can be considered by both, importers and exporters for obvious reasons such as ensuring the availability of drugs to the end-users i.e. patients, without compromising quality and compliance.
As Dr Ashok Omray, Advisor, Pharma Operations, Ex AVP, USV and Ex. President, ICPL opines, “Recent circular dated April 17, 2020, issued by the DGHS, CDSCO in connection with permission for the importation of drug products having even less than 60 per cent of residual shelf-life, maybe a fire fighting step under exceptional situations only. The goods having a low expiry period must be judiciously distributed for quick consumption to avoid wastage. Another important aspect is to ease the process of customs clearance, the current backlog is an exceptional situation.”
“This step is laudable if the goods have been awaiting a custom clearance or have been delayed due to transit problems and the relaxation is granted. But, I think it will be necessary to put a tab on this arrangement once normalcy is restored, besides the exporters and importers must be advised to strictly adhere to the norms already established,” added Dr Omray.
The expiration of the drug substances and drug products vary based on the formulation type, packaging and route of synthesis. In general, the expiration periods ranging from 18 months to 36 months. A few products may have shelf-life of up to 60 months under specified storage conditions. Generally, near expiry goods are withdrawn from the stockists by a company’s sales force and destroyed.
If the expiration period is only 18 months, at 60-70 per cent residual expiry, it leaves hardly one year for its last consumption. Ethically, the drugs must not be used after their assigned expiration period.
But, conditions apply
The DCGI’s letter informs that importers give an undertaking that the drug/s would be utilised or consumed before the expiry date. According to Rule 31 of the Drugs and Cosmetics Rules, 1945, “No drug shall be imported unless it complies with the standard of strength, quality and purity.” The licensing authority shall not allow the import of a drug with a less than 60 per cent residual shelf life as on the date of import. However, in exceptional cases, the licensing authority may, for reasons to be recorded in writing, allow the import of any drug with a lesser shelf life, but before its expiry.