The Karnataka State Registered Pharmacists Organisation (KSRPO) has requested government authorities to bring in a centralised enforcement department of drugs rules under the purview of the central government. It has suggested merging all the State and Central drugs enforcement departments into one union government department.
Ashokswamy Heroor, President, KSRPO, commented, “We have expressed the need to merge all the State and Central drugs enforcement departments into one Union government department and have written to different government authorities including PM Narendra Modi, DV Sadananda Gowda, Union Minister of Chemical and Fertilizers and Dr Harsh Vardhan, Union Minister of Health and Family Welfare. The aim of the proposed suggestion is to bring uniformity in actions against the offenders as well as functioning mechanisms in each State.”
He continued, “Presently, there is no uniformity in the State Drugs Department designations as well, for e.g.; the Maharashtra FDA Commissioner will be representing the food and drug department whereas, in the case of Karnataka, the drug controller officer of the state is from the State Health and Family Welfare Department. Therefore, there is a dire need to bring a centralised action directive to all states, and it should come under the Food and Drugs Administration along with uniformity in the designations.”
In its letter to the government authorities, the association has highlighted that the Central Drugs Standard Control Organization (CDSCO) implements rules concerned with import, approval of new drugs, clinical trials, the licence approval of Large Volume Parenterals (LVP) and blood bank licence, recombinant drugs, testing labs, medical equipment, diagnostic agents etc. It has further constituted the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), to amend existing laws; guide the State Drugs Controllers (DCs) on policy matters, control Pharmacopoeia Committee and Central Drugs Laboratory (CDL), and regulate pharmacy education through the Pharmacy Council of India. (PCI). Moreover, there are separate bodies to regulate and monitor other activities. The National Pharmaceutical Pricing Authority (NPPA) partially enforces price control regulations and the Narcotics Control Bureau (NCB) controls some aspects of the psychotropic substances rules.
Some chapters of the Drugs and Cosmetics Act and Rules are implemented by State authorities. The state Drugs Controllers are responsible for the quality of the drugs and cosmetics manufactured, marketed and their equitable distribution, in their states. However, they institute prosecution cases against the transgressors of various drugs rules. The respective authorities also enforce certain chapters of the Drugs (Prices Control) Order (DPCO), Essential Commodities Act, Narcotic Drugs & Psychotropic Substances Act and rules, Drugs and Magic Remedies (Objectionable Advertisements) Act, (DMROA) and rules etc., Besides this, they are also authorised for the Pharmacy Act, Pharmacy Practice Regulations (PPR), through state Pharmacy Council. And, they control Diploma in Pharmacy Education by a Board of Examining Authority and operate in the Drug Testing Laboratory (DTL) for testing legal samples.
The letter states, “Therefore, it may be noted that all these laws are jointly enforced by central and state government departments, which has resulted in chaos. Justice is not being done by either department. They are shirking their responsibilities. The process of investigation of interstate offences and punishing the guilty is the worst affected zone. State inspectors do not have legal jurisdiction beyond the taluka or district of their placement. They cannot take action beyond their jurisdiction, leave alone going to other states for investigation. Knowing this lacuna fully well, spurious drug manufacturers sell their items only in far off States and avoid apprehension and prosecution.’
The letter also highlights that if one State Drugs Controller refuses to grant manufacturing licence to an irrational or sub-therapeutic combination, the neighbouring States’ Drugs Controllers extends a red carpet welcome to them. Some states do not have a drug control department or have it, only for namesake, which results in substandard drugs manufactured in such states and sold all over the country. Among the states also there are no uniform yardsticks to take departmental action against offenders. In most states, the drugs control department is headed by a technical person. This results in maladministration.”
“We foresee the only remedy is to centralise all enforcement departments of drugs rules and to one department, under the purview of the central government. All these enactments are Central and hence it will not be difficult for the central government department to administer them. It will also reduce the duplication of staff and work and thereby save crores of rupees to the government exchequer, besides effective and meaningful implementation of all rules along with protecting public health,” informed Heroor.
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