The drug regulator should look at the various factors that go behind failing of a drug during pharma company sample test before finalising the list of Not of Standard Quality (NSQ) samples and publishing the details of the drugs which successfully pass the quality test among other details in order to improve the drug alert process, said a senior industry leader. Before releasing the list, the association has sought the drug regulator to provide a fair chance to the industry for verifying the same.
The comment comes in the backdrop of criticism that States like Himachal Pradesh, Uttarakhand have a high number of NSQs listed in the monthly drug alert list released by the drug regulator. While drug samples from other states are also declared as NSQ they are also in the list of drug alerts, said Dr Rajesh Gupta, All India Head with Laghu Udyog Bharti Pharmaceutical Committee and State President of Himachal Drug Manufacturers Associations, Baddi.
“While the drug alert list is very much publishing the details of the NSQ products it only gives the total number of products which passed the test. That also was included after we made a request some years back. Our request is to release the list of products which passed the Standard Quality test also, like the NSQs, to create confidence in the manufacturing team and mass public,” said Gupta.
India’s varied geography and climatic conditions should also be taken into consideration when looking into the issue of NSQs. The stability of the product is highly dependent on the climatic condition of the logistics and storage area and there are several challenges in this.
“Whatever is manufactured in the low temperature in a State like Himachal Pradesh are going to States like Gujarat, Maharashtra or Kerala, where the humidity varies and temperature is high. The storage condition in the retail and wholesale also needs to be checked. Many of the retailers and wholesalers are having limited refrigeration and air conditioning facilities. While these aspects can also impact the quality of the drug samples, only the manufacturer is getting targeted,” said Gupta.
“There should be improvement of storage conditions from the part of the wholesaler and the retailers too. Even in logistics, cold storages are only used by the wholesaler for vaccination. Many states are facing challenges in terms of power availability round the clock. When the outside temperature is crossing 45 or 46 degree celsius, most of the medicine needs to be stored in a temperature of less than 30 degree Celsius as per the standards. Whenever the sample is taken for testing, all the blame is on the manufacturer without giving the opportunity to explain a drug alert that has been released,” he added.
Besides, situations such as floods and other natural calamities in many parts of the country almost throughout the year have to be taken into account. If anything happens to the drug consignment, it should not be considered as the fault of the manufacturer alone.
The regulator should also record the storage condition, including the day temperature of that location when the drug administrative official draws samples from a retailer or wholesaler. While drawing the samples, they should also examine whether the wholesaler or the retailer is fulfilling the licensing conditions instead of testing and publicising the NSQ details only with the names of the manufacturers.
“When the NSQ list is published in the CDSCO website, many manufacturers challenge the report and their sample will get approved by the Central Drugs Laboratory. But the alert list is still maintained without any correction. Many times the large corporations declare the NSQ samples with their label as spurious, but it is not many times published later,” he averred.
He added that it is also important to mention how many samples of a particular state are drawn during a particular sample collection. If seven samples manufactured in Himachal Pradesh, Uttarakhand are declared as NSQ, it should also be mentioned that how many samples collected in total were from the State as in domestic industry both states, which contribute more than 70% of the market.
“There is a difference if those seven samples are out of a total of 2,000 samples manufactured in Himachal Pradesh or from a larger sample size of 5,000 or 7,000,” said Gupta, who added that his organisation has represented these points several times to the Ministry and regulators in the past.
It may be noted that one out of every third medicine consumed by Indians is from the pharma hubs of North India and it has been supplying medicines to the nook and corner of country through many challenges including during the lockdown owing to Covid-19 pandemic and various flood, cyclone situations over the past several years.
“We hope now from amendment of the Drugs & Cosmetics Act after 83 years about justice to Licencee and genuine manufacturers and hardcore punishment to spurious, copy product, unlicensed products generators of many part in India especially many cases found in post Covid era,” he opined.
The industry has conducted educational seminars for the workforce of the industry and requested the units to manufacture only those products that has stability and quality fully satisfied before releasing in the market under 2 to 3 years Expiry considering to above burning facts, he added.