LAHORE, July 31: The new drugs rules have barred medical stores in Punjab, whose number is in thousands, from selling 145 life-saving and other vital medicines in order to promote ‘pharmacy culture’.
The Punjab governor has notified the Punjab Drugs Rules 2007 under section 44 of the Drugs Act 1976. The rules have been revised after a gap of 19 years.
The Wholesale Chemists and Druggists Association’s Lahore chapter president, Nisar Chaudry, told Dawn that no stakeholder had been taken into confidence in the ‘very important’ process which he claimed was aimed at benefiting multi-nationals and promoting pharmacy culture in the province.
Under the new rules, the period of renewal of drug sale license has been reduced from two to one year. The licensing authority shall not renew a license without considering an inspection report submitted by an inspector.
The rule 20 (1) (e) says: “A licensee of a medical store shall not sell or store a drug mentioned in the schedule G”. The drugs included in this schedule are; for anti-leprosy - Rifampicin Injection, Dapsone, Clofamazine, Ethionamide and Prothionemide —, for immunological products, vaccines, sera\ant-sera - Vaccines of Anthrax, BCG, Botulisms Antitoxin, Cholera, Influenza, Measles, MMR, Rubella, Pneumococcal, Poliomyelitis, Smallpox, Typhoid, Rabiies and Homophiles Influenza Type B, and Immunoglobulins —, for products related with malignant diseases and immunosupression - Folinic Acid, Doxorubicin HCI, Mercaptopurine, Thioguanine, Vincristine, Cisplastin, Busulphan, Carmustine, Lomustine, Cyclophosphamide, Melphalan, Fluorouracil, Mitozantrone, Methottrexate, Vinblastine, Carboplatin, Bleoimycin, Chlorambucil, Dacarbazine, Amasascrine, Azathioprine and Cyclosporin - for anesthesia and inhalation anesthetics - Propofol, Enfluran, Isofluran, Halotha ne, Bupivacain, Thiopentone, Benzodiazepine, Mitazolam, Naloxone Hcl, Vancuronium, Pancuronium, Tubocuraine, Suxamethonium and Neostigmine - for antibiotics - Spectinomycin, Teicoplanon, Sodium Fusidate, Vancomycin, Colistin and Impenem - for inotropics - Primacor, Enoximone and Milrinone - for injection prostaglandins - Dinoprotone, Gemeprost AND Carboprost - for alpha blocker - Prazosin Hcl, Daxazosing, Indramine and Alfuzosin - for biotechnological products - Interferon and Erythropoetin - for narcotics, psychotropic and tri cyclic ant-depressant - Morphine, Buprenorphine, Nalbuphine, Fantanil, Pethidine, Lorazepam, Temazepam, Chlorpromazine, Melprobamate, Chlordiazepoxide, Alprozolam, Clonazepam, Flurazepam, Loprazolam, Oxazepam, Amoxapine, Iprine Dole Codine, Pentazocine, Lithium, Dextropropoxyphene, Clomipramine, Mianserin, Maprotiline, Dothiepin, Doxepin, Nortriptyline, Trimiprammine, Tranycypromine, Flupenthixol, Tryptophan, Imipramine and Amipriptyline - for anti-viral - Acyclovir, Amantadine Hcl, Famciclovir, Inosine Pranolsex, Zidovudine, Ganciclovir, Idoxuridine, Riavirin, Vidarabrin, Trifluridine and Methisozone - for thrombolytic enzymes - Alteplase, Streptokinase, Anislreplase and Urokinase - for dialysis - Peritoneal, Haemodialysis, Hyper tonic solution, Lysine solution and Isotonic solution - for creams and aerosols steroidal preparations — Methylprednislone, Dexamethasone, Hydrocortisone, Prednisolone, Tramcionolone and Beclomethasone - for hormones - Vasopressin, Desmopressin, Stanozolol, Nandrolone, Mesterlolone, Finasteride, Finasteriode, Somatropin, Testosterone and Progestrogens.
“Non-availability of such a large of number of drugs from about 50,000 medical stores in Punjab means creating a lot of trouble for patients as there are only few hundred pharmacies in the province, Nisar Chaudhry said. The role of wholesalers and distributors had also not been explained in the rules as well.
Besides this, the rules say the licensing authority shall not issue a license unless the premises of a pharmacy or medical store is clean and hygienic, has adequate facility for storage of drugs and for their protection from direct sunlight and dust.
Under the rules, an aggrieved party may file an appeal to the provincial appellate authority within 30 days of the date of the order issued by the licensing authority.
A nine-member provincial quality control board, headed by the provincial health secretary, has been constituted. The board may constitute a committee in a district to be known as the district quality control board. Both boards may meet at least once a month to review the situation of drugs’ quality control.
Before referring a case to a drug court, the provincial or district board shall ascertain the name of the director, partner, and employee of the company who is prima facie responsible for the commission of the offence under the Act or rules and may allow an inspector to institute prosecution against such person.
According to the rules, no person shall be appointed as an inspector unless he holds a degree in pharmacy from a university or an institution recognised by the Pharmacy Council of Pakistan and has at least one-year experience in manufacture, sale, testing and analysis of drugs.
