An alleged flaw in the existing Drugs Price Control Order (DPCO), which ignores the "superior quality" parameter while calculating the ceiling price of drugs, may deprive Indian patients from accessing some of the "best" medicines available.

In a classic case that demonstrates the situation, Jubilant Organosys, the makers of bulk drug "carbamazepine" have complained to department of chemicals that the recent steep downward revision of "carbamazepine" has made it unviable for the company to supply its quality product to its customers. The issue is related to the price fixation carried out by National Pharmaceutical Pricing Authority (NPPA) lowering the maximum selling price of carbamazepine from Rs 3080 per kg to Rs 2180 per kg. "Carbamazepine" is a life saving anti-epileptic drug meant for long term use in millions of patients across the country. While the price revision was based on a cost comparison between the product of Jubilant and a cheaper version produced by Sun Pharmaceutical Industries, Jubilant feels that the production of carbamazepine by the company involves several additional steps and maintains international standards whereby it cannot produce the bulk drug at a cost comparable to that of Sun Pharmaceuticals.

Interestingly, Jubilant is the only Indian company that manufactures carbamazepine from the very basic stage. Sun is importing low cost intermediates from China and carrying out only the later stage manufacturing activities in India. Jubilant complains that the same pattern cannot be adopted by the company as the particular Chinese intermediate is not recognized by world class drug administrators due to its increased share of impurities. It also points out to a similar decision taken by NPPA in 1999 and the resultant import of low cost import of carbamazepine from China which was finally stopped due to the intervention of the office of Drugs Controller General of India (DCGI).

The company explained that during 1997, 1998 and 1999, the formulators, tm,.raders used to import low cost carbamazepine from China and used to formulate. On testing the quality of carbamazepine of Chinese origin, the DCGI's Office had then found that carbamazepine of Chinese origin had high content of bromine and could be technically labeled as 'substandard quality'. This had led to the stoppage of imports from China, Jubilant has noted. The latest NPPA decision is also inviting a similar situation where Indian formulators will be compelled to depend solely upon Chinese carbamazepine of questionable standards, they fear.

According to Jubilant, controlling of impurities and producing the drug substance with zero bromine content is a tedious task and can be achieved only through a controlled process and with a good manufacturing facility. Jubilant also informed that the company is the only indigenous player that produces the drug from the basic stage while maintaining total control over impurities at each stage of production. It also reminds that carbamazepine bulk drug produced by Jubilant has the approval of the innovator company (Novartis) where the innovator had limited its bromine content to a maximum level of 50ppm. (DCGI had found that the Chinese imports had about 2000-4000 ppm of bromine in 1999)

The company finds even the previous price (Rs 3080 per kg) also as inadequate as there has been a constant increase in prices of input materials like solvents and fuel prices. "Our domestic sales are nearly 50 per cent of our total sales and we cater to almost 55-60 per cent of the Indian market requirement and as such reducing the maximum selling price by Rs 900 per kg will make us unviable. Our cost of production is nearly Rs 4765 per kg and the current price of Rs 2180 per kg will make the business completely unviable. It will not be possible for us to cater the quality product to our customers in India," the company has said.

The companies that are into the production of medicines of international standards feel that the NPPA should undertake a technical study in association with the office of the Drugs Controller General of India and ascertain the facts on quality and efficacy of the standard quality of bulk drug used. The additional cost incurred by the company in ensuring the best quality should be considered while fixation of prices, they feel. The NPPA sources however said that "quality" cannot be a parameter as of now, as it is not mentioned in the existing DPCO.

With the government busy finalizing the new DPCO, pharma majors feel that the introduction of any clause giving consideration to quality parameters in DPCO would help avoid such situations in future.