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Express Tribune
12 hours ago
- Health
- Express Tribune
Cabinet exempts import of unregistered drugs
Listen to article The government has approved exemption for the import of certain unregistered drugs, which will be used in hospitals and institutions. The National Health Services, Regulation and Coordination (NHSR&C) Division apprised the cabinet in a recent meeting that the Drug Regulatory Authority of Pakistan (DRAP) was mandated to regulate the manufacturing, import, export, distribution and sale of therapeutic goods as well as enforce the Drugs Act, 1976. The division shared that access to unapproved therapies for patients was a global phenomenon and drug regulators around the world provided special mechanisms for such access under certain conditions to ensure the availability of lifesaving drugs. It was highlighted that the World Health Organisation's Global Benchmarking Tool for regulatory practices also included mechanisms to provide access to unapproved therapeutic products in the interest of public health. The NHSR&C Division apprised the forum that Section 36 of the Drugs Act stipulated that the federal government may, if it is of the opinion that the public interest so requires, at any time, of its own motion or on a representation made to it, by notification in the official gazette, exempt any drug or class of drugs from the operation of any of the provisions of this Act, subject to such conditions, if any, and for such period, as may be specified in the notification. The division said that the import of any drug that was not registered or was not in accordance with the conditions of registration was prohibited under Section 23(1)(a)(vii) of the Drugs Act. However, exemption was granted to hospitals and institutions for the import of anti-cancer drugs, cardiac drugs and any essential lifesaving drugs, as considered by the licensing authority, under certain conditions prescribed in SRO 134(1)/2021 dated February 24, 2021. The exemption was given to provide access to innovative therapies that were yet to be registered under the Drugs Act. The five-year exemption expired on January 21, 2025. The NHSR&C Division told the cabinet that DRAP, in its 198th meeting held on January 27, 2025, recommended a five-year extension in the exemption period, starting from January 22, 2025, for anti-cancer drugs, cardiac drugs and any essential lifesaving drugs, as considered by the licensing authority. These drugs were to be imported for use in hospitals and institutions under Section 23(1)(a)(ii) of the Drugs Act, subject to following conditions: Imports shall be made with prior approval of the licensing authority under Rule 9 of the Drugs (Import and Export) Rules, 1976. The drug shall not be sold or distributed in the market. It shall be on free sale in the country of origin except for lifesaving vaccines and anti-sera for human use only, where pre-qualification by the World Health Organisation (WHO) or approval from any regulatory authority, as defined by the registration board, is provided. The drug shall be used for therapeutic purposes in hospitals or institutions only, and not for the purpose of clinical trials, examination, testing or analysis. A clearance certificate must be obtained from the assistant director concerned at the time of arrival of the shipment, before Customs' clearance. Consumption or utilisation record must be maintained by the importer, under the supervision of a qualified person. The drug is not registered or available in Pakistan, provided that the condition mentioned in Serial No (c) shall not apply to medicines and vaccines used in the treatment and prevention of Covid-19. A draft notification, vetted by the Ministry of Law and Justice, was also placed before the cabinet for consideration. During discussion, cabinet members inquired about the rationale for the proposed exemption, responding to which the NHSR&C Division explained that the import or local production of such essential lifesaving medicines was not commercially viable as the number of patients requiring those medicines was limited. Therefore, hospitals and institutions were constrained to import them. The cabinet considered a summary titled "Exemption for Import of Certain Unregistered Drugs for Use in Hospitals and Institutions" and approved the proposals.
Business Recorder
3 days ago
- Health
- Business Recorder
TIP urges govt to implement generic medicine policy
ISLAMABAD: Transparency International Pakistan (TIP), while advocating for the promotion of generic based medicines to end consumers, urged the government to implement the generic medicine policy to purchase and prescribe medicines with generic name only to benefit the masses. In a written letter to Federal Minister for National Health Services and Regulations Mustafa Kamal, the TIP has also recommended the government to use of least cost method in public sector procurement of drugs which are registered and approved by the Drug Regulatory Authority of Pakistan (DRAP) to save annually billion of rupees to the exchequer and citizens. TIP refers to its letters dated 22 April 2021 and 9th June 2021 addressed to the managing director, Public Procurement Regulatory Authority (PPRA) and officer of the prime minister. TIP has highlighted the need that drugs/medication be made available to the ordinary citizens at the cheapest price possible. In this regard, the chief executive officer of DRAP issued an advisory to all provinces and federal controlled units, on 16th April 2021, to ensure that doctors prescribe medicines with their generic names instead of brand names, in the public and private sector throughout the country as this practice adds to the economic burden of the country. However, this policy is facing failure of implementation. According to Drug Regulatory Authority of Pakistan Act, 2012 (DRAP Act), and under Article 7, Powers and functions of the Authority, all Medicines/Drugs shall be approved and registered with DRAP, and that DRAP is the only approving authority in Pakistan for quality of medications and once it registers a medicine, for example Aspirin, it means that the Aspirin's quality and MRP is approved by DRAP. The TIP has also drawn a comparison between the cheapest and costliest medicines of same generic, for instance an Aspirin 10 tablet pack manufactured by Karachi Pharmaceutical Laboratory was available at Rs47 while same medicine manufactured by another company Euro Pharma International was available at Rs300 per pack. From above examples it can be seen that on average branded medicines prices are 3,000 percent to 4,000 percent higher than approved non-branded medicines. When generic medicine policy is implemented, public will get 90 percent relief in medical expenses. The best international practices highlight that a generic medicine system is often considered beneficial for a national health policy due to its potential to improve affordability, accessibility, and efficiency in healthcare. This is because: Generic medicines are significantly cheaper and cost-effective than the brand-name drugs. Generic medicines increase access as lower costs mean more people, especially in low- income or underserved populations, can afford essential medications. In Pakistan, where affordable healthcare is a problem for wider section of the society, generic medicines can promote equitable healthcare access and help address disparities in treatment across socioeconomic groups. Generic medicines can also foster competition in the pharmaceutical market in Pakistan, which can drive down prices further and incentivise innovation in cost-effective drug production. TIP requests the Federal Minister for Health to look into TI Pakistan's recommendations, probe into non-implementation of generic medicine guidelines despite clear directives of the past and issues directives on implementing generic medicine policy to save billions to the national exchequer and the citizens of Pakistan. The TIP is striving for across the board application of Rule of Law, which is the only way to stop corruption, and achieve against Zero tolerance against Corruption. Copyright Business Recorder, 2025
Ottawa Citizen
3 days ago
- Business
- Ottawa Citizen
Who decides who stays and who goes during workforce adjustment?
Article content In each individual department and agency, the responsibility to determine which positions are affected by workforce adjustment, lies with the deputy head. Article content Managers have the responsibility and authority, in consultation with human resources, to determine the merit criteria and assessment methods to be used in the SERLO process. They also evaluate and make decisions on who gets retained and who gets laid off. Article content Team leaders may be involved with the evaluation of their own team, which again exposes the process to favouritism and bias. Article content Before engaging in the SERLO process, the employer must establish a voluntary departure program for any workforce adjustment situation involving five or more employees in the same group, level or unit. Article content If five or more employees in the same work unit are deemed to be affected, the employer must determine if there any volunteers for departure with compensation. It is very important that employees understand this step prior to having to compete for their jobs. Article content Article content The SERLO process only causes more anxiety and stress to an already extremely stressful situation. It raises concerns of reprisals and the ugly truth of having to compete against a co-worker to keep your job — a job both you and co-workers have already been deemed qualified for. Article content A seniority-based process would be more transparent and equitable. Article content During DRAP (deficit reduction action plan), which was introduced by the Conservative government in 2012-14, the SERLO process was widely used to eliminate close to 40,000 jobs and it was a complete disaster. Article content If the Liberal government is intending on going ahead with the announced cuts, they would be well advised to consider changes to the SERLO process. Article content Employees in all departments and agencies are worried about their futures; however, the workforce adjustment directive provides them with certain rights and outlines the employers' obligations. Article content Article content Remember, if you receive a letter telling you your position is impacted by workforce adjustment, that does not mean you will necessarily lose your job. But you will need to understand what happens next in the process. Article content Many of the federal public service unions have updated their websites to include the latest information on the SERLO process. The National Joint Council has information available. The Public Service Commission website also includes a managers' guide that is also helpful for employees. Article content Unfortunately, workforce adjustment situations will be a reality in the federal public service in the coming months and years, and it will be very stressful. Article content If you need help, reach out to your union, a co-worker or a friend. Sometimes it helps just to talk it out.
Business Recorder
31-07-2025
- Business
- Business Recorder
Meeting discusses forming Pak-Russia JVs in pharma sector
ISLAMABAD: Pakistan and Russia, Wednesday, discussed and reviewed bilateral relations in industrial cooperation especially starting on joint ventures in pharmaceutical sector. In this connection a meeting was held here under the chairmanship of Special Assistant to the Prime Minister (SAPM) on Industries and Production, Haroon Akhtar Khan, on insulin imports from Russia and joint ventures. The meeting was attended by Denis Nazarov, Representative of the Russian government, senior officials from the Ministry of Industries and Production, Ministry of National Health Services, and the Drug Regulatory Authority of Pakistan (DRAP). Discussions focused on the import of insulin from Russia, progress on pharmaceutical joint ventures, and the development of protocols for policy board implementation. The meeting was informed that the DRAP had earlier granted registration to Genetics Pharmaceuticals, Lahore, for the import of insulin from Russian company Zavod Medsintez. The meeting also discussed the matters related to the application of Eli Lilly's for an increase in maximum retail price (MRP). The officials informed the meeting that if the DRAP is considering the application of the insulin manufacturer, then it will become costlier than the insulin of Novo Nordisk Pharma, another European insulin maker. SAPM Haroon Akhtar Khan emphasised that the establishment of a pharmaceutical joint venture between Pakistan and Russia marks a significant milestone in strengthening bilateral relations. He noted that Pakistan is a major consumer of insulin, and the regular supply of insulin from Russia could greatly benefit diabetic patients across the country. He stated that in line with government's vision, efforts are under way to initiate local manufacturing of insulin in Pakistan. A joint protocol between local manufacturers and Russian companies is expected to be finalised and presented soon. Haroon Akhtar Khan directed all stakeholders to develop a comprehensive proposal prior to its presentation in the federal cabinet. Copyright Business Recorder, 2025
Express Tribune
31-07-2025
- Business
- Express Tribune
In pharma JV, Pakistan to import Russian insulin
Listen to article Pakistan is set to import insulin from Russia with the help of joint ventures between pharmaceutical companies of the two countries. In that regard, a high-level meeting was held under the chairmanship of Special Assistant to Prime Minister (SAPM) on Industries Haroon Akhtar Khan. Russian government representative Denis Nazarov, senior officials of the Ministry of Industries and Production, Ministry of National Health Services and Drug Regulatory Authority of Pakistan (DRAP) were present in the huddle. Discussions focused on the purchase of insulin from Russia, progress on pharmaceutical joint ventures and the development of protocols for policy implementation. It was noted that DRAP had earlier granted permission to Genetics Pharmaceuticals, Lahore, for the import of insulin from Russian firm Zavod Medisintez. Haroon Akhtar emphasised that the establishment of a pharmaceutical joint venture between Pakistan and Russia marks a significant milestone in strengthening bilateral relations. He noted that Pakistan is a major consumer of insulin and its regular supply from Russia could greatly benefit diabetic patients across the country. He stated that in line with Prime Minister Shehbaz Sharif's vision, efforts are underway to initiate local manufacturing of insulin. In this connection, a joint protocol between local manufacturers and Russian companies is expected to be finalised soon. He directed all stakeholders to develop a comprehensive proposal. Sources revealed that a registration letter for the import of insulin from Zavod Medisintez was issued by DRAP on May 5, 2025 in favour of Genetics Pharmaceuticals. Subsequently, the company applied for an increase in the maximum retail price (MRP) on the basis of a rise in the Consumer Price Index (CPI), which is allowed under the Drug Pricing Policy, 2018. A revised MRP letter was issued to Genetics Pharmaceuticals on June 16, 2025. The manufacturer is demanding the MRP quoted by the originator brand of insulin, Eli Lilly. However, the importer has not so far submitted any application and justification for the increase in MRP. It is relevant to mention that leading local manufacturers, Getz Pharma and BF Bio Sciences, are selling locally manufactured insulin at MRPs equal to or lower than the MRP permitted for insulin import from Russia. If the MRP of Russian-manufactured insulin is increased, it will be higher compared to that of another European company, Novo Nordisk Pharma. The importer has two options to apply for increase in the MRP of insulin imported from Zavod Medisintez: an application may be submitted under the hardship category as per paragraph 9 of the Drug Pricing Policy, 2018 and the importer should submit evidence of import in commercial quantity from Russia. The MRP will be calculated on the basis of import price of the vaccine based on the value determined by Pakistan Customs on goods declaration under the Customs Act, 1969. The MRP will be based on the following formula: trade price = landed cost + 40% mark-up. The landed cost includes the import price converted into Pakistani rupees, customs duty, import levies and expenses. The MRP will be calculated by grossing up the trade price to provide for 15% retail discount. Hardship applications will be considered by the drug pricing committee and the MRP determined on the basis of above formula will be placed before the DRAP policy board. After endorsement by the board, the recommended MRP will be considered by a cabinet committee and its recommendation will be placed before the cabinet for approval.
