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(source : ANI) ( Photo Credit : ani)
New Delhi [India], October 6 (ANI): The Indian Medical Association has defended the arrest of a paediatrician amid child deaths from contaminated cough syrup in Madhya Pradesh and called the arrest a classical example of legal illiteracy of the police officials. The IMA further requested immediate action against the perpetrators and adequate compensation for the bereaved families.
The IMA, in a press release, condemned the arrest and said, The cough syrup tragedy in Madhya Pradesh and the subsequent arrest of the doctor who prescribed the same is a classical example of legal illiteracy of the officials and the police. IMA demands immediate action on the actual culprits and adequate compensation for the affected families and the doctor who is a victim of defamation.
The FIR was lodged at Parasia police station on Saturday on a paediatric specialist posted at the Community Health Centre (CHC) in the town, along with the directors of M/s Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu. They have been booked under BNS sections 105 (culpable homicide not amounting to murder) and 276 (adulteration of drugs), as well as section 27(A) of the Drugs and Cosmetics Act, 1940.
The release further said, The arrest of the doctor in haste, just after the report of BMO, precisely shows an attempt to divert the attention of the people from the faults of regulatory bodies and the concerned pharmaceutical company.
Highlighting the reason behind the use of cheap materials, the press release said that pharmaceutical-grade glycerine and propylene glycol, required for manufacturing cough syrups, are expensive. Toxic substances such as industrial-grade DEG and ethylene glycol (EG) are cheaper and visually indistinguishable.
The IMA further criticised the quality control and said that if quality control fails at the level of both the manufacturer and the regulator, cough syrups produced by a few companies may end up containing toxic substances capable of causing kidney failure and death in young children. This has happened several times in the past in multiple countries among children after apparently consuming contaminated cough syrup. The prescribing doctor has no way of knowing whether a medicine is contaminated until adverse outcomes are reported among patients who have taken it.
The release further added, Regulation must therefore be made foolproof to prevent such tragedies. Many people purchase cough syrups over the counter without a doctor recommendation, resulting in far more children consuming them than medically necessary. In most cases, coughs and colds resolve on their own without any syrup. When a doctor does prescribe one, it is based on clinical assessment of the child.
The release cited the Mashelkar Report of 2003. It noted that the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the State and Central level, inadequate testing facilities, shortage of drug inspectors, no uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, non-existence of a data bank and non-availability of accurate Information.
In the given case, CDSCO and MPFDA failed to monitor the concentration of DEG in the alleged cough syrup. The responses of both Central and State authorities are creating problems instead of instilling confidence in the minds of the public. Arresting a doctor who has the mandate and privilege to prescribe a drug as approved by competent authorities has sent a wrong message. Doctors across the country are apprehensive after indiscriminate action against a bona fide doctor. This is a clear-cut case of a spurious drug as defined in Section 17 B of the Drugs and Cosmetics Act. (Sec 17 B. d: it has been substituted wholly or in part by another drug or substance).
Approval of the said cough syrup, monitoring of the quality and the content of the same, squarely fall within the ambit of the Drugs regulatory system. Once the drug has been approved and made available in the market registered medical practitioner is the legitimate authority in prescribing any drug. The Drug Controller issuing directions to the pharmacies not to supply an approved drug falls outside their competency and authority. The controller has issued such advices to the pharmacies earlier as wellas restricting certain drugs to certain specialities. This amounts to a coloured exercise of power outside the boundaries of the Drugs and Cosmetics Act, said the release.
IMA further highlighted their concern with the incompetence and inadequacy of the drug regulatory system in the country and the mishandling of this unfortunate incident. The onus of the death of these hapless children falls squarely on the manufacturers and the authorities. Intimidation of the medical profession is uncalled for and will be resisted, the release said. (ANI)
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