Anti-rabies vaccine not available in market

LAHORE: The Primary and Secondary Healthcare Department (P&SHD) Punjab has taken notice of unavailability of Anti-Rabies Vaccine (ARV) in the market, leading to fatal incidents in the province.

In this regard, the Punjab chief drugs controller wrote to the pharmaceutical manufacturers and importers to explain their position vis-à-vis shortage of the drug in the market.

Despite increasing incidents of dog biting, there's a severe shortage of anti rabies vaccine in Pakistan. However, representatives of pharmaceutical industry believe that the authority to sanction lot release of vaccine – National Control Laboratory (NCL), does not have the federal drug analyst for the last couple of months, resulting in many life-saving drugs and vaccines stuck in warehouses.

In a note, dated August 4, 2020, addressed to M/s Sanofi Aventis, Pakistan, Karachi, M/s Hakimsons Impex (Pvt), Ltd, Karachi, M/s Novartis Pharma (Pvt) Ltd, Karachi, M/s Cirin Pharmaceuticals (Pvt) Ltd, Hattar, M/s Hospital sale and services, Karachi, M/s Hi-Warble Pharmaceuticals (Pvt) Ltd, Lahore, M/s Gene Tech Import, Karachi, M/s Atlantic Pharmaceuticals, Peshawar, and M/s Sindh Medical Store, Karachi, a copy of which is also forwarded to the chief executive officer of the Drug Regulatory Authority of Pakistan (DRAP), Islamabad, the Punjab chief drugs controller said that the Anti-Rabies Vaccine (ARV), being essential drug, is indicated for pre-exposure and post-exposure prophylaxis of rabies. Rabies, if untreated, is almost always fatal and ARV, along with anti-rabies immunoglobulin, is the sole treatment of rabies. Therefore, non-availability of such a drug may lead to fatal incidents. The shortage of the drug is a clear violation of the Drugs (Licensing, Registration and Advertising Rules, 1976), Rule 30 (4) & (7), which states: “Every drug should be produced in sufficient quantity so as to ensure its regular and adequate supply in the market. “In case of an imported drug, the indenter or any other approved representative in Pakistan of the foreign firm shall ensure regular and adequate supply of the drug in Pakistan.” The Punjab chief drugs controller has directed the pharmaceutical companies/ importers to immediately restore the supply of the vaccine and explain their position, along with provision of current stock status of the drug. Meanwhile, a spokesman for the P&SHD said there was no shortage of the Anti-Rabies Vaccine anywhere in the province. In this regard, he said there were 3,326 units of seven different brands available including 1,501 units of Rabio, 1,449 of Adhayrab, 318 of Indirab, 50 of Verorab, two each of Iyssavac and Rubbivac and four units of Equirab.

giving details of Anti-Rabies Vaccines at health facilities of Punjab till 20-8-2020, the P&SHD spokesman said that there were a total of 37,468 ARV units available in Punjab including 14,000 at the provincial store, 403 at Attock, 894 at Bahawalnagar, 231 at Bahawalpur, 171 at Bhakkar, 1,508 at Chakwal, 750 at Chiniot, 1,089 at Dera Ghazi Khan, 749 at Faisalabad, 502 at Gujranwala, 300 at Gujrat, 382 at Hafizabad, 419 at Jhang, 292 at Jhelum, 319 at Kasur, 583 at Khanewal, 689 at Khushab, 252 at Lahore, 757 at Layyah, 801 at Lodhran, 289 at Mandi Bahauddin, 414 at Mianwali, 551 at Multan, 1,154 at Muzaffargarh, 144 at Nankana Sahib, 657 at Narowal, 1,453 at Okara, 740 at Pakpattan, 381 at Rahim Yar Khan, 2,482 at Rajanpur, 223 at Rawalpindi, 481 at Sahiwal, 874 at Sargodha, 391 at Sheikhupura, 1,435 at Sialkot, 83 at Toba Tek Singh, and 665 at Vehari. The Pakistan Chemists and Druggists Association (PCDA) has, meanwhile, written a letter, dated 21-08-2020, to Dr Faisal Sultan, Special Assistant to Prime Minister (SAPM) on Health, NHS/R&C, Islamabad, drawing his attention to pending appointment of the federal government analyst at the National Control Laboratory in Islamabad. “For over two months, supplies of critically life-saving biological products, which have already been imported, stand suspended; due to the fact that there is no federal government analyst present at the NCL for issuing lot releases for such shipments. “Patients nationwide have no recourse to address critical ailments at this time. We have been sending reminders to the CEO DRAP and health minister's office, since the beginning of June 2020, but nothing has happened till date.”

The federal government analyst is responsible for issuing lot releases for imported and locally manufactured biological products, such as anti-snake venom, rabies vaccine, tetanus vaccine, typhoid vaccine, insulin, medicines for coronavirus patients, medicines for dialysis patients and cancer patients, and many more such products. “This is a very urgent matter; therefore, it is requested to take immediate action to get this notification issued without any further delay,” says Khalid Saeed, chairman PCDA.