The Pesticides Manufacturers & Formulators Association of India (PMFAI) has urged Prime Minister Narendra Modi to reject a five-year Regulatory Data Protection (RDP) regime for agrochemicals, accusing multinational companies and importers of repeatedly pushing for the provision despite earlier parliamentary scrutiny.

 

In a letter to Modi, PMFAI President Pradip Dave said the association, which represents 221 Indian pesticide manufacturers and formulators, was opposing what it described as an attempt to extend protection for agrochemicals beyond the existing 20-year patent period.

 

The association said the issue had been examined by multiple government ministries over the past 16 years and claimed that reviews had consistently recommended against introducing such provisions.

 

PMFAI pointed in particular to the Parliamentary Standing Committee on Agriculture, Animal Husbandry and Food Processing, which examined the Pesticides Management Bill and submitted its 36th report to the Seventeenth Lok Sabha in December 2021.

 

According to PMFAI, the committee concluded that the existing 20-year patent period was sufficient for innovators to recover investments in new molecules, provided those molecules were introduced in India within the patent period.

 

The association also cited the committee's view that India's large and growing agrochemical market and extensive arable land would continue to attract new molecules from both foreign and domestic companies even without data protection.

 

Despite this, PMFAI alleged that multinational companies and importers continue to press for five-year data protection through the proposed Pesticide Management Bill.

 

PMFAI warned that extending protection beyond the patent period could restrict generic competition and increase costs for farmers.

 

"The molecules for which Regulatory Data Protection (RDP) is sought are already developed, registered, and commercialized globally long before introduction into India. Consequently, RDP in India would reward past innovation rather than stimulate future innovation."

 

The association further argued that India has provided 20 years of patent protection since joining the international patents regime in January 2005, and described data protection or exclusivity as a "TRIPS plus measure" that could delay the entry of generic agrochemicals.

 

PMFAI also rejected what it described as an argument that data protection is necessary to encourage the first introduction of new molecules in India.

 

"The MNC lobby is trying to mislead authorities by stating that Data Protection is the only way for the first introduction of new molecules, while the fact is that – any new molecule is introduced with Patent protection and enjoys 20 years period of Patent Protection, which is sufficient period for an inventor to recover the investment and sufficient amounts of profits from all over the world in discovery of new molecule."

 

The association further alleged that some Western multinational companies that did not commercialise patented products in India are now seeking five-year protection to introduce older, off-patent molecules into the Indian market.

 

"The western MNCs who failed to commercialise their patented products in India are the ones, now actively lobbying for Data Protection / Data Exclusivity to bring their old and off patented molecules to Indian market with 5 years protection (market exclusivity)."

 

PMFAI said India's domestic pesticide industry has built substantial capabilities in process chemistry, manufacturing innovation and cost-efficient production. It argued that Indian manufacturers continue to develop alternative manufacturing routes and improved production technologies after product patents expire.

 

The association's central concern, however, is the potential impact on farmers. It claimed that five-year data exclusivity could delay generic competition and push pesticide prices higher.

 

"If Data Protection or Data Exclusivity granted beyond patent period of 20 years, Farmers in the country will suffer most as they will be compelled to buy pesticides (crop protection products) at high prices ranging from 35% to 50% more cost, as Data Exclusivity will prevent entry of Generic products in the market and thereby stop competition in the market place."

 

PMFAI also warned that restrictions on generic launches could affect India's agrochemical exports and global competitiveness.

 

The association has therefore asked the Prime Minister to direct the Department of Agriculture & Farmers Welfare not to accept demands for regulatory data protection and to ensure that neither RDP nor data exclusivity is incorporated into the Pesticide Management Bill.

 

"The registration framework should not become a vehicle for securing indirectly what has previously not been accepted through the legislative process."

 

PMFAI concluded by urging the government to reject the proposed five-year protection, arguing that the move would affect Indian agriculture, farmer interests, domestic manufacturing, market competition and food security.