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Thursday, May 23, 2024

Contract Manufacturing Policy for Pharmaceuticals gets Government approval

New Policy was long awaited, country’s pharma manufacturers had been pressing hard for this new Contract Manufacturing Policy to improve their capacities to develop synergies with international pharmaceutical companies and they believe, with active government support, they can quadruple exports within the next five years.

The Ministry of National Health Services, on Friday, vide SRO 1347 (1) 2021 dated 15th October 2021 issued a long awaited revised contract manufacturing policy for the pharma industry. Objective is to facilitate the industry to develop synergies through contract manufacturing arrangement. This is considered a major achievement by the Pakistan Pharmaceutical Manufacturing Association (PPMA) that has vowed to quadruple its exports, by crossing the billion-dollar mark, within the next five years.  

The new contract manufacturing policy was approved by the federal government in its cabinet meeting after long deliberations with the pharma manufacturers. Tauqeer Haq, the outgoing Chairman PPMA (CEO Sante Pharma) and Jalal ud Din Zafar, (Chairman Technical Committee PPMA and Sr General Manager Nabiqasim & Surge Pharma Group) have played an important role in convincing officials in Ministry of Health, Drug Regulatory Authority of Pakistan (DRAP) and Ministry of Commerce that this policy will help boost the capacity of the industry. 

Govt sees pharma as an industry with export potential

Pakistan’s Pharma industry is small as compared to regional giants like India and China. Its national market is worth around US $ 3.5 billion (PKR 550 billion) and its latest export figures hover between US $ 250-280 million, much smaller as compared to Textiles, and IT. However, it is a knowledge intensive industry and has been steadily growing over the last two decades and government experts have assessed that industry has significant export potential – if encouraged through the right policies. 

pharmaceuticals (PPMA)

Imran Khan government is eager to increase the country’s exports; and with this new policy it aims to boost the confidence and capacity of the domestic pharma producers, encourage foreign investments, and pave the way for the pharmaceutical industry to invest in new FDA/MHRA & EU GMP approved facilities. PM’s Advisor on Commerce and Investments, Razzaq Dawood has emerged a strong supporter of export-oriented businesses in the federal cabinet and according to industry sources his support was crucial. 

The new Contract Manufacturing Policy 2021 defines a strict relationship between what it defines as the “Contract Giver” and “Contract Acceptor”. It has lifted the restrictions imposed earlier on the number of products allowed for contract manufacturing by the “Contract Giver” and will now allow the companies to get as many as intended products manufactured under contract manufacturing arrangement. However, the new policy still limits the “Contract Giver” to be engaged in manufacturing of pharmaceutical products, and the concept of allowing contract manufacturing for a local marketing/ franchising company of drugs still remains restricted.

Read more: Pharma Export Summit and Awards: Chairman Tauqeer Ul Haq’s Address

How New Contract Manufacturing Policy Helps Industry grow?

The new policy allows the importer of already registered drugs to develop import substitution locally through contract manufacturing arrangement with a registered pharmaceutical manufacturer from DRAP and has also facilitated the foreign pharmaceutical companies (including marketing authorization holders from Reference Regulatory Authority like the US, Canada, UK, Australia, EU or Japan) to get their relevant products registered in their own name under contract manufacturing arrangement with the registered pharmaceutical manufacturer in Pakistan. 

This was earlier allowed only to the foreign pharmaceutical manufacturers. This practice will allow international pharmaceutical marketing companies to invest in Pakistan for marketing, sales and promotion of their international brands in Pakistan and create job opportunities and contribute positively towards the economy.

Read more: Pakistan’s Pharma: An Industry Set to Rise

The new policy has further allowed the international exporters to get their products / branded generics manufactured in Pakistan without any hassle and is likely to encourage the pharmaceutical manufacturers in Pakistan to set-up FDA/ EMA/UKMAHRA/TGA/ PICS / WHO approved pharmaceutical manufacturing facilities in Pakistan; as their risk for not having all dosage forms for a molecule/ branded generic will now be mitigated through facilitation of contract manufacturing arrangements with other counterparts. 

Pakistani pharmaceutical companies were earlier handicapped due to the previous restrictive contract manufacturing policy, and the business opportunity for contract manufacturing of international brands was often lost to the Indian, Chinese and Bangladeshi pharmaceutical manufacturers. 

However, with this new policy and anticipated synergies thereon, it is very likely that Pakistani pharmaceutical manufacturing companies will soon emerge in the global arena as a highly reliable resource for contract manufacturing of branded generics of international trading and marketing companies owning marketing authorizations across the globe. 

The Pakistan Pharmaceutical Manufacturers’ Association (PPMA) has expressed its gratitude and has thanked the H.E. Prime Minister Imran Khan, Razak Daud (Advisor on Commerce & investments to Prime Minister Imran Khan) & Dr. Faisal Sultan (Special Assistant to Prime Minister Imran Khan on National Health Services) for approving and issuing this long-awaited contract manufacturing policy pending and paving the way to develop synergies and boost pharmaceutical Exports from the country.  

Read more: Pakistan’s first ever Pharma export Awards being held on September 29