Sukesh. C. Khajuria hits out at double standards in dealing with infant deaths due to unchecked spurious, adulterated drugs
Jammu, May 15
Eminent social activist Sukesh C. Khajuria in a letter written to the Drug Controller General ofIndia (DCGI) with copies to his counter parts in Jammu and Kashmir, Punjab, Haryana and Himachal Pradesh has questioned the double standards in dealing with the deaths of infants in foreign countries vis-a-vis those who died in India due to alleged spurious drugs manufactured in India.
Appreciating the action being initiated against Indian pharmaceutical companies manufacturing spurious drugs which had reportedly caused deaths of infants in foreign lands resulting in an outcry at the international level about the standards of drug manufactured in India, Sukesh C.Khajuria said that It was a happy development that action has been initiated in the shape of joint inspections, cancellation of licenses of 18 pharmaceutical companies and notices to 26 others in this matter. But he insisted that it needed to be done on a sustained basis.
However, while, appreciating these action following international outcry following deaths of foreign infants, Sukesh .C. Khajuria said that it was regrettable that tangible action in to deaths of infants in similar circumstances happening in India are missing. “My concern is whether the deaths of Indian infants is different from deaths of foreign infants,” he questioned.
He informed the Drug authorities that he had taken up with the National Human Rights Commission the issue of deaths/ deformities of infants in Northern India following consumption of unchecked spurious and adulterated drugs in the case no.80/09/14/2020 in NHRC seeking compensation for the families of the victims of Ramnagar tehsil of distt. Udhampur of J&K , which the Commission graciously granted and subsequently upheld by the High court of Jammu and Kashmir [case wp(c) No 388 of 2021] and Supreme Court of India [ SLP(c) No 8345/2021 ] despite objections by the J and K Government where majority of the deaths took place in 2019-20.
He further brought to the r notices of drug authorities the sad and untimely death of several children and severe deformities to others in some parts of northern India due to consumption of spurious drugs since December, 2019. As a senior social activist of UT of J and K, he had been highlighting these unfortunate deaths and deformities of infants in Jand K, Punjab, Haryana and Himachal Pradesh.A total of 16 deaths took place in North India, 13 in Ramnagar tehsil of Distt.Udhampur and one in Bishnah tehsil, distt. Of Jammu in UT of J&K, one child died at Baddi in Himachal Pradesh and another died at Patiala in Punjab. Eight children who consumed unchecked spurious and adulterated drugs were disabled, six of them in Udhampur district with disabilities ranging from 40 per cent to 85 per cent while another child at panchakula in Harayana suffered 100 per cent disability. Another child at Patiala has been found with disabilities.
The FIR no 21/2020 dated 02-03-2020 at police station kala Amb, district Sirmaur in Himachal Pradesh, FIR no.33/2020, dated 03-03-2020 at police station Ramnagar in Udhampur district of Jammu and Kashmir and FIR no 0182/2020 dated 05-03-2020 at police station Mahesh Nagar, Ambala Cantt. Haryana were registered against companies manufacturing spurious & adulterated drugs.
He said that in view of inadequate response from drug controlling agencies and a larger mafia operating in different States, it was found that there was a lack of coordination between the Central and State governments on regulatory measures to check and punish such unscrupulous elements who are manufacturing and selling spurious drugs in connivance with quacks and corrupt drug authorities.
Twelve infants/children had lost their lives in Ramnagar area/tehsil Udhampur district of J&K after consuming “Coldbest-PC syrup” manufactured by M/S Digital Vision, 176 Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmaur, HP 173205, marketed by M/s Orison pharmaceuticals 51, Industrial Estate, Ambala Cantt. On a complaint by J&K administration, the Himachal Pradesh Police had registered a case of attempt to commit culpable homicide and under the provisions of The Drugs and Cosmetics Act against M/S Digital Vision, A Pharmaceutical Firm at Kala Amb in Sirmaur District which manufactured the “Coldbest-Pc Syrup”.
A two year old child, Radhika d/o Monu (M- 78076-53688), permanent resident of Kanhari, Hardoi-Uttar Pradesh-241123 ( Aadhar card Number 5349 2196 0929), and presently residing near Sabzi Mandi, Baddi H.P. was admitted in advanced Paediatrics Centre, PGIMER, Chandigarh on 22nd July with renal failure vide CR No:202002621258. The child was administered a number of drugs on the prescription of Dr. Diwanchand S/o Sita Ram, Ward no. 2, Baddi, Solan, HP 173205. The PGIMER gotit analysed in Paediatric BiochemistryLab for the presence of diethlyene glycol (DEG) qualitativelyusing GCMS and confirmed by searching on NIST library.
In PGIMER Chandigarh’s preliminary assessment, one of the drugs consumed by the child wasCofset-AT (Ambroxol Hydrochloride, Terbutaline Sulphate, Guaiphenesin, Menthol) manufactured byDigital Vision and marketed by Orison Pharmaceuticals 51, Industrial Area, Ambala Cantt DL5200 [Mfg. date 09-19, Exp 08- 21] was found to have Diethylene Glycol DFEG (reference : (For Extraction)K.J.Mulligan: No 4042-A procedure to determine Diethylene Glycol (2,2’-oxybisethanol) and ethylene glycol (1,2,ethanediol) in glycerine and selected products, laboratory Information bulletin 12(7), DHHS (1996) chromatogram attached is in a serious condition and undergoing treatment at PGI, Chandigarh.
Another infant, Anmol Sharma, age 02 years, S/O Pradeep Kumar, Labour and resident of Shambu,district Patiala died at Govt. Medical college Hospital Sector-32 Chandigarh. Another child, Sarabjeet Singh a five year old son of Avtar Singh, a car mechanic of Shambu, district Patiala is struggling between life and death due to consumption of spurious/poisonous syrup manufactured by Digital Vision in Patiala district of Punjab. The Cold Best –PC syrup which was given to the children contained Diethylene glycol (DEG) and spurious drug which is a banned drug. The drug is banned in some states and the United States Food and Drug administration had warned in 2011 against the use of the drug to children below five years of age.
Sukesh.C. Khajuria said that the Government Analyst, Regional Drugs Testing Laboratory (RDTL) Chandigarh has furnished its report of Test and Analysis conducted on the suspected drug i.e. Cold Best-PC Syrup on Form-13 vide no. LSD/RDTL/1758/19- 20, DT: 02-03-2020 with the following remarks: “In the opinion of the undersigned the sample referred to above is not of standard quality as defined in the Drugs and Cosmetics Act, 1940, and Rules there under for the reason given below: The sample does not conforms to claim as per Patent &amp; Proprietary in respect to the pH and the Assay of Phenylephrine Hydrochloride” Further, the sample has been tested for Diethylene Glycol (DEG) and found positive for the same and content of Diethylene Glycol (DEG) is 34.24%
The Patiala police has filed two FIRs:- FIR NO : 0029 /0027/2020 U/s 328/304 IPC 1860 and the Indian Medical Council Act 1956 U/s 15(3) at police station Shambu, District Patiala, Punjab. But theaccused medical practitioner Garja Singh and his son Kulwinder have been granted bail by the court.
Interestingly, the medical practitioner against whom cases have been registered by Patiala police has contended that he had only prescribed the medicine which was manufactured by M/s Digital Vision pharmaceutical company, 176 Mauza Ogli, Nahan, Kala Amb, District Sirmaur, Himachal Pradesh, against whom number of cases have been registered and has already been prosecuted at different places for preparing spurious drug. Different states have already banned the sale of “Cold Best- PC syrup”.
According to extended Licencing Laboratory and legal Node, a database that tracks instances of substandard medicines, there have been seven cases from 2014 to 2019 when drugs manufactured by Digital Vision were found to be ‘not of standard quality’. Khajuria said that these revelations are just the tip of the iceberg and many innocent lives are at stake due to a mafia comprising owners of spurious drug manufacturing units, functionaries of Drug Controllers of different States. This mafia and inaction of other authorities are playing with the lives of innocent people.
He further said that the National Human Rights Commission (NHRC) has already taken cognizance of his complaint regarding the deaths of infants due to consumption of spurious drugs in Ramnagar area of Udhampur district in December-January 2019-2020 and reprimanded the J and K drug authorities. The NHRC has issued a show cause notice to the J and K government seeking action taken report against “the delinquent officials, on account of whose negligence such incident had occurred, which could otherwise be averted due totheir strict vigil”.
Sukesh.C.Khajuria lamented that there has been no action taken against the erring drug control officials who allegedly collided with these spurious drug manufacturing companies and are responsible for infants’ deaths. He requested the drug authorities to take appropriate against drug controlling authorities of different states including J and K where such spurious drugs are being sold blatantly. He further said that any such punitive action would meet the ends of justice to the bereaved infants and victim families and act as a deterrent against any such misdemeanour by drug mafia in future.