New Delhi: As many as 67 medicines were found to be ‘not of standard quality’ (NSQ) in the course of their random sampling conducted by drug regulatory authorities in September. The laboratories of the Union government drug regulator, the Central Drugs Standards Control Organisation (CDSCO), found 49 drugs to be NSQ, while state labs found 18 to be NSQ.
In a press interaction with ANI, Doordarshan and NDTV, drug controller general of India (DGCI) Rajeev Raghuvanshi said the CDSCO had collected 3,000 samples for testing in September.
The results of the lab investigation carried out on these samples were released on Friday (October 25).
The results of the random sampling conducted in a particular month are released in the next month.
Two lists of NSQ drugs – one made by the CDSCO and one compiled by the CDSCO from lists by state drug regulatory authorities – are released every month.
An analysis of the lists for August and September reveals that the names of six companies appear in both months. That is, they were found to be offenders not once but twice as far as the two months are concerned.
These firms are Hindustan Antibiotics, Life Max Cancer Laboratories, Alkem Health Sciences, Digital Vision, Nestor Pharmaceuticals and Kerala Medical Services Corporation.
Four companies – Zee Laboratories, ANG Lifesciences India, Himalaya Meditek and Protech Telelinks – saw their names figure only in September, but more than one of their products that month was found substandard.
The list of these companies and the NSQ drugs can be found in the table below.
Also read: The Curious Case of a ‘Killer’ Drug With Contradictory Toxin Test Results at Different Govt Labs
What are substandard drugs?
According to the Drugs and Cosmetics Act, 1940, medicines that are unfit for consumption are divided into three broad categories:
1. Contaminated or adulterated drugs are medicines in which an adulterant has been found mixed. This can lead to serious injuries, including death due to contamination, especially with a toxin.
2. Spurious drugs are fake drugs that contain the label of a particular pharmaceutical company but are not manufactured by it.
3. Substandard or NSQ drugs are medicines in which a particular ingredient is not present in the quantity in which it is supposed to be. This, in turn, would make the drug less effective against a particular disease and, therefore, aggravate it. But unlike a contaminated drug, death may not necessarily occur due to the poor quality of the drug per se.
The Drugs Consultative Committee (DCC) of the CDSCO specifies two kinds defects in substandard drugs – minor and grossly substandard. A drug is usually declared substandard by a regulator mostly when it is grossly substandard. The parameters for this are:
(i) Active ingredient contents are 5% below the quantity in which they are supposed to be for thermostable drugs (drugs whose efficacy is vulnerable to fluctuations in temperature); and 70% below for thermolabile products (drugs not vulnerable to temperature changes).
(ii) Tablets/capsules fail the disintegration or dissolution test (to check the drug’s ability to be absorbed in the body)
(iv) Liquid preparations show presence of fungus in the drugs
(v) Drugs are not sterile, fail the pyrogen/endotoxin test or have undue toxicity (caused due to bacteria that might creep in due to unhygienic conditions at any step of drug manufacturing)
(vi) Vaccines fail in potency, sterility, toxicity or moisture content.
Drugs failing standards test
A majority of the 67 drugs that found mention in the September lists were anti-hypertensive drugs like telmisartan; antibiotics like metronidazole, gentamycin and ceftriaxone; calcium and vitamin supplements; antacids like pantoprazol; antidiabetics like glimepiride and metformin; cough syrups; drugs to prevent blood clotting; and pain-relief drugs like diclofenac and nimesulide plus paracetamol.
The full list of drugs found NSQ by the CDSCO in September can be found here, and by state labs, here.
It must be noted here that results from only seven states or Union territories are present in the state list for September.
The others did not submit data to the CDSCO and it is hence unknown if they conducted random sampling or did conduct it but did not release the results. These include Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Goa, Gujarat, Haryana, Himachal Pradesh, Manipur, Rajasthan, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Pondicherry, Telangana, Delhi, Uttarakhand, West Bengal, Andaman and Nicobar Islands, Dadar and Nagar Haveli and Daman and Diu, and Lakshadweep.
Most of the 67 drugs failed the assay test (done to measure the amount of ingredient present), dissolution and disintegration tests and endotoxin tests.
DGCI Raghuvanshi clarified during the press event that if a drug’s name figures in the list, it should not be construed that the drug as made by all manufacturers is NSQ.
A drug maker’s name is mentioned against an NSQ drug in the list. It is only that particular manufacturer whose drug is under the radar.
Action taken
Asked about action taken against companies whose names figured in the previous monthly lists, Raghuvanshi said during the press meet that they were served notices and asked to withdraw their NSQ drug from the market.
However, there is no clarity on whether these withdrawals really occurred and if the CDSCO or the state drug regulators have a system to track the process.
DCC guidelines say that if drugs are found to be grossly substandard, if “criminal intent” or “gross negligence is established” and where it is found that “administrative measures would not be sufficient to meet the ends of justice”, a case should be filed in a court of law.
In the absence of any of these conditions, “[the] weapon of prosecution [filing a case in court] should be used judiciously, where it is felt that administrative measures like suspension or cancellation of licences or compounding of offences would not meet the ends of justice,” the guidelines say.
It is not certain whether any drug makers who figured in previous monthly lists were found to have “criminal intent”, if “administrative measures” like the suspension of their licence took place or if a case was filed against any of them in court.
The Wire called and texted Raghuvanshi to seek these clarifications but did not immediately receive a response.
