The Federation of Pharma Entrepreneurs (FOPE), a federation of around 700 drug manufacturing units in the tax-free zones of Himachal Pradesh and Uttarakhand, has urged Prime Minister Dr Manmohan Singh to amend Section 36AC of the recently notified Drugs & Cosmetics Act to exclude licensed manufacturers from its provisions and also to amend 36AC(b) to make a distinction between offences relating to adulterate/spurious drugs and other offences of minor nature like substandard drugs.

FOPE general secretary Vinod Kalani said that an amendment in Drugs & Cosmetics Act is necessary to safeguard the legitimate and genuine licensed drug manufacturers in the country as the new bail provisions under section 36 AC of the Act is equivalent to TADA & POTA. Otherwise, it will be very difficult to operate under such pressure, and most of the legitimate pharma entrepreneurs would gradually look for some other avenues and would not like to involve their next generation into pharmaceutical manufacturing.

The rigid bail provisions under 36AC are primarily meant for criminals and antisocial elements involved in pushing spurious/adulterated drugs in the market. But, these bail provisions, 36AC(b), are applicable even on licensed manufacturers for offences of minor nature including substandard drugs. Since there is no distinction in the newly amended Act between offences relating to adulterated and spurious drugs and other offence of minor nature, there will be arrest even in cases of substandard drugs.

There is fear in the industry due to the past experiences. In the past, charges of spurious and adulterated were framed against licensed manufacturers by the authorities in majority of the cases filed in the court of law for substandard drugs.

Urging the PM to amend the Act further, FOPE said that the 36AC(b) bail provisions should not be applicable on licensed manufacturers. In case any licensed manufacturer is found involved in making spurious drugs, his license should be cancelled first and then 36AC can be applied, it said.

"If 36AC remains as such then we fear that no respected person in the society would like to continue in business of drug manufacturing in India, especially in SME segment as any one can harass legitimate and genuine manufacture and one has to live under constant threat of arrest for no fault," FOPE in its letter to the PM said.

The FOPE demanded that the guidelines cleared in the 40th DCC meeting should either be notified or given a legal shape after including certain observation which are necessary for safeguarding the interest of original, genuine and innocent manufacturers and suppliers.