The multinational companies (MNC) do not want the US government to frame regulatory pathways or guidelines immediately for the recombinant drug industry. They, as lobbying against framing pathways, fear that the move will allow less expensive version of recombinant products mostly from countries like India and China to enter US, once they become generics, said some of the speakers assembled at the First World Congress on Nano-Biotechnology, scheduled from June 21-23, in Mumbai.

The pathways act as a reference document for recombinant protein manufacturers outside US to export their products to US following procedures laid out in it. Even Europe has not framed regulatory pathways for biogenerics, where regulators are facing stiff resistance from the MNCs.

In the next 2-3 years biogenerics like EPO, G-CSF and Interferon will lose their patents. However, due to the absence of a regulatory framework for biogeneric exports, MNCs will continue with the monopoly of marketing these biopharmaceuticals in the advanced markets.

To make it simple, regulatory pathways are similar to guidelines for generic pharmaceutical exports that need to be followed for setting up a GMP compliant manufacturing facility and guidelines for filing ANDA or DMF applications.

Since two genes are not alike, however strictly you follow the manufacturing protocol, there could arise variation in the bio-equivalence level of the same recombinant proteins manufactured in two separate regions, unlike the pharmaceutical products.

An EPO or G-CSF or Interferon is currently priced very high in the US. With the takeover of generic manufacturers, the price of these products would reduce to one-seventh of the current prices, said experts. According to a speaker, 40 million population in US surprisingly finds it difficult to pay for their primary healthcare needs.

On the positive side, biopharmaceuticals meet four of the seven elements needed for successful generics competition, according to consultancy firm Arthur D Little. These include large market size, high prices for the original branded product, limited impact on the cost of goods sold on the branded price and simple, non-proprietary formulation systems. However, whether biopharmaceuticals meet three additional criteria -the availability of active substance produced through non-infringing routes, well-characterized actives with easy to match specifications and manageable costs for demonstrating bioequivalence-is still constrained by legal, regulatory and technological issues.

"Without regulatory pathways, an exporter of generic biopharmaceuticals will have to test his product right from the animal studies to the three phases of clinical trials, in order to prove bioequivalence and bioavailability in patients in US or Europe, which is a very expensive affair. Also, MNCs have an upper hand if any litigations arise.

Pathways are like law, which will protect the interests of the exporter. With proper regulatory guidelines, the number of tests to prove the efficacy of the product can also be brought down," said a foreign bank official at the conference.

The conference was organised by the Mumbai-based Chemtech Foundation.